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GQ
GQ Magazine is a leading men's lifestyle magazine which covers fashion, grooming, politics, entertainment, sports, and more. The website offers the latest news and trends in fashion and style, as well as reviews and features on gadgets, cars, and accessories. Its articles are authored by leading industry experts, providing comprehensive information on popular culture and current events. The site is user-friendly, with easy navigation tools and search options, allowing readers to find a range of content tailored to their interests. GQ Magazine's online platform is a must-visit destination for fashion-conscious men looking to stay ahead of the curve in a constantly evolving sphere.
The geometric style of this font with different color combinations makes this font logo suitable for economic, industrial, news networks, and fun activities.hyperpix.netThe GQ magazine’s logo font uses a circle-shaped geometric font. These two letters are transparent colored so that the letter ‘Q’ is placed on the letter ‘G’ or vice versa.
nytimes.comWill Welch, the 41-year-old editor of GQ, towered over the other pedestrians as he walked along Church Street in Lower Manhattan on the first night of New York Fashion Week.
GQ includes articles on a wide variety of men's interests, including fashion, food, sex, sports, grooming, movies, women, travel, technology, music, fitness, politics, books and more.magazines.comEvery sophisticated, stylish, intelligent gentleman looks to GQ as a trusted resource for fashion advice and everything else to keep him on top of his game.
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EncryptedSite is Encrypted
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CountryHosted in Ireland
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CityDublin, Leinster
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Latitude\Longitude53.3379 / -6.2591 Google Map
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Traffic rank#6,694 Site Rank
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Site Owner informationWhois info
Website is Safe
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Editor-in-chiefWill Welch
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CategoriesMen's
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FrequencyMonthly
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PublisherCondé Nast Inc.
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Total circulation934,000 (2019)
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First issue1931
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CompanyAdvance Publications
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Based inNew York City
Traffic rank
#6,694
#6,694
Site age
Location
Ireland
Ireland
Popular Questions for GQ
Newest job postings for GQ
via Salary.com
posted_at: 10 days agoschedule_type: Full-time
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and... make a difference.
QLP: GQ Quality Laboratory
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and... make a difference.
QLP: GQ Quality Laboratory Practices (QLP) serves as the GLP Quality Assurance Unit which inspects and audits each nonclinical laboratory safety study to assure quality and compliance with Good Laboratory Practice and other applicable regulations and departmental procedures. Audits of internal processes critical to the conduct of nonclinical laboratory studies and contract research organizations used for the conduct of GLP studies are also responsibilities of GQ-QLP as well as assisting stakeholders with regulatory advice and preparation for regulatory agency inspections.
Principal Objective of the Position
This is an auditing position where knowledge and understanding of the regulatory framework, regulatory requirements, processes, systems and procedures matures. More independence is gained in evaluating preclinical operations against regulatory requirements, policies and procedures, identifying areas of noncompliance, and recommending appropriate remedial actions.
Key Responsibilities and Major Duties
• Continue to develop an in-depth knowledge of governmental regulations which impact upon the research and development of medicines as well as the most relevant Bristol Myers Squibb Company policies and procedures associated with preclinical research
• Conduct Good Laboratory Practices audits and inspections of preclinical studies for the purpose of assessing compliance with governmental regulations and established operating procedures:
• Review study protocols, amendments and deviations.
• Schedule and conduct inspections of study activities.
• Prepare and submit written reports of these inspections to study director and management.
• Audit final reports and raw data for these studies.
• Perform Good Laboratory Practice systems audits at various BMS sites and/or functional areas, as well as at contract research organizations, for the purpose of assessing regulatory compliance:
• Compile documentation in preparation for the audit.
• Prepare clearly written, accurate, and evidence-based audit reports to effectively communicate the audit findings to the auditees and management.
• Review and assess corrective action plans and follow-up on the resolution of audit findings.
• Keep clear and detailed documentation on every audit planned, performed and followed.
• Regularly update the GQ-QLP audit database, generate, review and maintain required reports (e.g., master schedule, findings reports, etc.). Perform trending analysis of findings as required.
• Assist in the preparation of departmental standard operating procedures.
• Participate in preparation and conduct of regulatory training (e.g., GLP training) of personnel involved in the conduct of preclinical studies.
• Provide assistance to other GQ-QLP personnel during inspections by regulatory agencies (e.g., FDA, USDA, etc.).
• Conduct other audits or investigations of regulatory concern as directed by management (e.g., Animal Welfare Practices, Controlled Substances, etc.)
• Adherence to BMS core behaviors
(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)
Key Stakeholders/Contacts describe key internal matrix relationships and list key external stakeholders/clients
• Daily collaboration with other GQ-QLP auditors in the preparation, conduct, reporting and follow up of audits and inspections. Relationships with other auditors should include sharing of knowledge and mentoring of less experienced auditors or associate auditors
• Regular contacts with technical, supervisory, and management personnel in the conduct and reporting of internal audits and inspections.
• Interaction with scientific and managerial personnel at contract research organizations during the evaluation of these facilities
• Close working relationship with external auditors and inspectors (FDA, USDA, etc.) during the conduct of their inspections
• Regular and appropriate reporting relationship to GQ-QLP management.
Key Competencies
• Basic knowledge of regulatory requirements for preclinical research
• Effectively communicated verbally and in writing and able to impact and influence people
• Computer literacy
• Strong critical thinking to analyze complex situations and discern critical issues
• Commitment to quality
• Able to analyze and interpret complex problems/data gathered from a variety of sources
• Able to meet high requirements within tight deadlines and adapt to changing priorities
• Accountable for actions and results
• Works effectively with a range of technically and culturally diverse people, including regulatory agency personnel.
• Good Judgement and sense of discretion
Travel Required (nature and frequency)
Approximately 10% travel may be required in this position. These trips will include travel to BMS sites and contract research organizations to conduct audits and to attend professional meetings and seminars.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to [ Link removed ] - Click here to apply to GQ-QLP Manager. Visit[ Link removed ] - Click here to apply to GQ-QLP Managerto access our complete Equal Employment Opportunity statement.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Recommended Skills
• Forecasting
• Business Administration
• Budgeting
• Analysis
• Accounting
• Auditing Show more details...
QLP: GQ Quality Laboratory Practices (QLP) serves as the GLP Quality Assurance Unit which inspects and audits each nonclinical laboratory safety study to assure quality and compliance with Good Laboratory Practice and other applicable regulations and departmental procedures. Audits of internal processes critical to the conduct of nonclinical laboratory studies and contract research organizations used for the conduct of GLP studies are also responsibilities of GQ-QLP as well as assisting stakeholders with regulatory advice and preparation for regulatory agency inspections.
Principal Objective of the Position
This is an auditing position where knowledge and understanding of the regulatory framework, regulatory requirements, processes, systems and procedures matures. More independence is gained in evaluating preclinical operations against regulatory requirements, policies and procedures, identifying areas of noncompliance, and recommending appropriate remedial actions.
Key Responsibilities and Major Duties
• Continue to develop an in-depth knowledge of governmental regulations which impact upon the research and development of medicines as well as the most relevant Bristol Myers Squibb Company policies and procedures associated with preclinical research
• Conduct Good Laboratory Practices audits and inspections of preclinical studies for the purpose of assessing compliance with governmental regulations and established operating procedures:
• Review study protocols, amendments and deviations.
• Schedule and conduct inspections of study activities.
• Prepare and submit written reports of these inspections to study director and management.
• Audit final reports and raw data for these studies.
• Perform Good Laboratory Practice systems audits at various BMS sites and/or functional areas, as well as at contract research organizations, for the purpose of assessing regulatory compliance:
• Compile documentation in preparation for the audit.
• Prepare clearly written, accurate, and evidence-based audit reports to effectively communicate the audit findings to the auditees and management.
• Review and assess corrective action plans and follow-up on the resolution of audit findings.
• Keep clear and detailed documentation on every audit planned, performed and followed.
• Regularly update the GQ-QLP audit database, generate, review and maintain required reports (e.g., master schedule, findings reports, etc.). Perform trending analysis of findings as required.
• Assist in the preparation of departmental standard operating procedures.
• Participate in preparation and conduct of regulatory training (e.g., GLP training) of personnel involved in the conduct of preclinical studies.
• Provide assistance to other GQ-QLP personnel during inspections by regulatory agencies (e.g., FDA, USDA, etc.).
• Conduct other audits or investigations of regulatory concern as directed by management (e.g., Animal Welfare Practices, Controlled Substances, etc.)
• Adherence to BMS core behaviors
(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)
Key Stakeholders/Contacts describe key internal matrix relationships and list key external stakeholders/clients
• Daily collaboration with other GQ-QLP auditors in the preparation, conduct, reporting and follow up of audits and inspections. Relationships with other auditors should include sharing of knowledge and mentoring of less experienced auditors or associate auditors
• Regular contacts with technical, supervisory, and management personnel in the conduct and reporting of internal audits and inspections.
• Interaction with scientific and managerial personnel at contract research organizations during the evaluation of these facilities
• Close working relationship with external auditors and inspectors (FDA, USDA, etc.) during the conduct of their inspections
• Regular and appropriate reporting relationship to GQ-QLP management.
Key Competencies
• Basic knowledge of regulatory requirements for preclinical research
• Effectively communicated verbally and in writing and able to impact and influence people
• Computer literacy
• Strong critical thinking to analyze complex situations and discern critical issues
• Commitment to quality
• Able to analyze and interpret complex problems/data gathered from a variety of sources
• Able to meet high requirements within tight deadlines and adapt to changing priorities
• Accountable for actions and results
• Works effectively with a range of technically and culturally diverse people, including regulatory agency personnel.
• Good Judgement and sense of discretion
Travel Required (nature and frequency)
Approximately 10% travel may be required in this position. These trips will include travel to BMS sites and contract research organizations to conduct audits and to attend professional meetings and seminars.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to [ Link removed ] - Click here to apply to GQ-QLP Manager. Visit[ Link removed ] - Click here to apply to GQ-QLP Managerto access our complete Equal Employment Opportunity statement.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Recommended Skills
• Forecasting
• Business Administration
• Budgeting
• Analysis
• Accounting
• Auditing Show more details...
via LinkedIn
posted_at: 12 days agoschedule_type: Full-time
For more than 50 years, GQ has been the premier men’s magazine, providing definitive coverage of style and culture. With its unique and powerful design, work from the finest photographers, and a stable of award-winning writers, GQ reaches millions of leading men each month. The only publication that speaks to all sides of the male equation, GQ is simply sharper and smarter.
Job... Description
Location:
New York, NY
GQ is looking for a Visuals
For more than 50 years, GQ has been the premier men’s magazine, providing definitive coverage of style and culture. With its unique and powerful design, work from the finest photographers, and a stable of award-winning writers, GQ reaches millions of leading men each month. The only publication that speaks to all sides of the male equation, GQ is simply sharper and smarter.
Job... Description
Location:
New York, NY
GQ is looking for a Visuals Production Coordinator to join our team. This role manages the day-to-day responsibilities of all cover and fashion production as well as model casting for branded, digital, and print shoots. Candidates should be able to balance multiple projects and deadlines at once and be eager to learn more about media. This position reports to the Global Visuals Production Director and is located in New York City.
Responsibilities include:
• Provide production and administrative support to the visuals department.
• Produce cover and fashion shoots with guidance from the Global Visuals Production Director; coordinate with global creative and editorial teams.
• Assist in the casting for all models for GQ print, digital, and branded content shoots.
• Option and secure crew, studios, catering, and all other production elements.
• Process invoices, COIs, advance requests, talent contracts, location contracts, and reconcile budgets for all shoots and handle expense reports.
• Maintain artist, agent, and producer relationships.
• Provide editorial and creative support in shaping daily publication on all platforms.
Required Skills & Qualifications:
• Knowledge of digital, social, and video content.
• Highly organized, detail oriented, and excellent communication skills.
• Ability to contribute to editorial decisions and support the development of visual stories across all platforms.
• Can creatively translate the needs of the brands into high quality output through a detailed understanding of the requirements of the platforms.
• Positive attitude and grace under high pressure situations due to day-to-day contact with high profile photographers and talent.
Base Pay Range: $56,500 - $65,000
What happens next?
If you are interested in this opportunity, please apply below, and we will review your application as soon as possible. You can update your resume or upload a cover letter at any time by accessing your candidate profile.
Condé Nast is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, age, familial status and other legally protected characteristics Show more details...
Job... Description
Location:
New York, NY
GQ is looking for a Visuals Production Coordinator to join our team. This role manages the day-to-day responsibilities of all cover and fashion production as well as model casting for branded, digital, and print shoots. Candidates should be able to balance multiple projects and deadlines at once and be eager to learn more about media. This position reports to the Global Visuals Production Director and is located in New York City.
Responsibilities include:
• Provide production and administrative support to the visuals department.
• Produce cover and fashion shoots with guidance from the Global Visuals Production Director; coordinate with global creative and editorial teams.
• Assist in the casting for all models for GQ print, digital, and branded content shoots.
• Option and secure crew, studios, catering, and all other production elements.
• Process invoices, COIs, advance requests, talent contracts, location contracts, and reconcile budgets for all shoots and handle expense reports.
• Maintain artist, agent, and producer relationships.
• Provide editorial and creative support in shaping daily publication on all platforms.
Required Skills & Qualifications:
• Knowledge of digital, social, and video content.
• Highly organized, detail oriented, and excellent communication skills.
• Ability to contribute to editorial decisions and support the development of visual stories across all platforms.
• Can creatively translate the needs of the brands into high quality output through a detailed understanding of the requirements of the platforms.
• Positive attitude and grace under high pressure situations due to day-to-day contact with high profile photographers and talent.
Base Pay Range: $56,500 - $65,000
What happens next?
If you are interested in this opportunity, please apply below, and we will review your application as soon as possible. You can update your resume or upload a cover letter at any time by accessing your candidate profile.
Condé Nast is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, age, familial status and other legally protected characteristics Show more details...
via LinkedIn
posted_at: 9 days agoschedule_type: Full-time
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and... make a difference.
QLP GQ Quality Laboratory
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and... make a difference.
QLP GQ Quality Laboratory Practices (QLP) serves as the GLP Quality Assurance Unit which inspects and audits each nonclinical laboratory safety study to assure quality and compliance with Good Laboratory Practice and other applicable regulations and departmental procedures. Audits of internal processes critical to the conduct of nonclinical laboratory studies and contract research organizations used for the conduct of GLP studies are also responsibilities of GQ-QLP as well as assisting stakeholders with regulatory advice and preparation for regulatory agency inspections.
Principal Objective of the Position
This is an auditing position where knowledge and understanding of the regulatory framework, regulatory requirements, processes, systems and procedures matures. More independence is gained in evaluating preclinical operations against regulatory requirements, policies and procedures, identifying areas of noncompliance, and recommending appropriate remedial actions.
Key Responsibilities and Major Duties
• Continue to develop an in-depth knowledge of governmental regulations which impact upon the research and development of medicines as well as the most relevant Bristol Myers Squibb Company policies and procedures associated with preclinical research
• Conduct Good Laboratory Practices audits and inspections of preclinical studies for the purpose of assessing compliance with governmental regulations and established operating procedures
• Review study protocols, amendments and deviations.
• Schedule and conduct inspections of study activities.
• Prepare and submit written reports of these inspections to study director and management.
• Audit final reports and raw data for these studies.
• Perform Good Laboratory Practice systems audits at various BMS sites and/or functional areas, as well as at contract research organizations, for the purpose of assessing regulatory compliance
• Compile documentation in preparation for the audit.
• Prepare clearly written, accurate, and evidence-based audit reports to effectively communicate the audit findings to the auditees and management.
• Review and assess corrective action plans and follow-up on the resolution of audit findings.
• Keep clear and detailed documentation on every audit planned, performed and followed.
• Regularly update the GQ-QLP audit database, generate, review and maintain required reports (e.g., master schedule, findings reports, etc.). Perform trending analysis of findings as required.
• Assist in the preparation of departmental standard operating procedures.
• Participate in preparation and conduct of regulatory training (e.g., GLP training) of personnel involved in the conduct of preclinical studies.
• Provide assistance to other GQ-QLP personnel during inspections by regulatory agencies (e.g., FDA, USDA, etc.).
• Conduct other audits or investigations of regulatory concern as directed by management (e.g., Animal Welfare Practices, Controlled Substances, etc.)
• Adherence to BMS core behaviors
(Disclaimer The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)
Key Stakeholders/Contacts describe key internal matrix relationships and list key external stakeholders/clients
• Daily collaboration with other GQ-QLP auditors in the preparation, conduct, reporting and follow up of audits and inspections. Relationships with other auditors should include sharing of knowledge and mentoring of less experienced auditors or associate auditors
• Regular contacts with technical, supervisory, and management personnel in the conduct and reporting of internal audits and inspections.
• Interaction with scientific and managerial personnel at contract research organizations during the evaluation of these facilities
• Close working relationship with external auditors and inspectors (FDA, USDA, etc.) during the conduct of their inspections
• Regular and appropriate reporting relationship to GQ-QLP management.
Key Competencies – Knowledge, Skills, Abilities, Other
• Basic knowledge of regulatory requirements for preclinical research
• Effectively communicated verbally and in writing and able to impact and influence people
• Computer literacy
• Strong critical thinking to analyze complex situations and discern critical issues
• Commitment to quality
• Able to analyze and interpret complex problems/data gathered from a variety of sources
• Able to meet high requirements within tight deadlines and adapt to changing priorities
• Accountable for actions and results
• Works effectively with a range of technically and culturally diverse people, including regulatory agency personnel.
• Good Judgement and sense of discretion
Travel Required (nature And Frequency)
Approximately 10% travel may be required in this position. These trips will include travel to BMS sites and contract research organizations to conduct audits and to attend professional meetings and seminars.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations Show more details...
QLP GQ Quality Laboratory Practices (QLP) serves as the GLP Quality Assurance Unit which inspects and audits each nonclinical laboratory safety study to assure quality and compliance with Good Laboratory Practice and other applicable regulations and departmental procedures. Audits of internal processes critical to the conduct of nonclinical laboratory studies and contract research organizations used for the conduct of GLP studies are also responsibilities of GQ-QLP as well as assisting stakeholders with regulatory advice and preparation for regulatory agency inspections.
Principal Objective of the Position
This is an auditing position where knowledge and understanding of the regulatory framework, regulatory requirements, processes, systems and procedures matures. More independence is gained in evaluating preclinical operations against regulatory requirements, policies and procedures, identifying areas of noncompliance, and recommending appropriate remedial actions.
Key Responsibilities and Major Duties
• Continue to develop an in-depth knowledge of governmental regulations which impact upon the research and development of medicines as well as the most relevant Bristol Myers Squibb Company policies and procedures associated with preclinical research
• Conduct Good Laboratory Practices audits and inspections of preclinical studies for the purpose of assessing compliance with governmental regulations and established operating procedures
• Review study protocols, amendments and deviations.
• Schedule and conduct inspections of study activities.
• Prepare and submit written reports of these inspections to study director and management.
• Audit final reports and raw data for these studies.
• Perform Good Laboratory Practice systems audits at various BMS sites and/or functional areas, as well as at contract research organizations, for the purpose of assessing regulatory compliance
• Compile documentation in preparation for the audit.
• Prepare clearly written, accurate, and evidence-based audit reports to effectively communicate the audit findings to the auditees and management.
• Review and assess corrective action plans and follow-up on the resolution of audit findings.
• Keep clear and detailed documentation on every audit planned, performed and followed.
• Regularly update the GQ-QLP audit database, generate, review and maintain required reports (e.g., master schedule, findings reports, etc.). Perform trending analysis of findings as required.
• Assist in the preparation of departmental standard operating procedures.
• Participate in preparation and conduct of regulatory training (e.g., GLP training) of personnel involved in the conduct of preclinical studies.
• Provide assistance to other GQ-QLP personnel during inspections by regulatory agencies (e.g., FDA, USDA, etc.).
• Conduct other audits or investigations of regulatory concern as directed by management (e.g., Animal Welfare Practices, Controlled Substances, etc.)
• Adherence to BMS core behaviors
(Disclaimer The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)
Key Stakeholders/Contacts describe key internal matrix relationships and list key external stakeholders/clients
• Daily collaboration with other GQ-QLP auditors in the preparation, conduct, reporting and follow up of audits and inspections. Relationships with other auditors should include sharing of knowledge and mentoring of less experienced auditors or associate auditors
• Regular contacts with technical, supervisory, and management personnel in the conduct and reporting of internal audits and inspections.
• Interaction with scientific and managerial personnel at contract research organizations during the evaluation of these facilities
• Close working relationship with external auditors and inspectors (FDA, USDA, etc.) during the conduct of their inspections
• Regular and appropriate reporting relationship to GQ-QLP management.
Key Competencies – Knowledge, Skills, Abilities, Other
• Basic knowledge of regulatory requirements for preclinical research
• Effectively communicated verbally and in writing and able to impact and influence people
• Computer literacy
• Strong critical thinking to analyze complex situations and discern critical issues
• Commitment to quality
• Able to analyze and interpret complex problems/data gathered from a variety of sources
• Able to meet high requirements within tight deadlines and adapt to changing priorities
• Accountable for actions and results
• Works effectively with a range of technically and culturally diverse people, including regulatory agency personnel.
• Good Judgement and sense of discretion
Travel Required (nature And Frequency)
Approximately 10% travel may be required in this position. These trips will include travel to BMS sites and contract research organizations to conduct audits and to attend professional meetings and seminars.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations Show more details...
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