Senior Manager, Specialty Laboratory QA - Bristol Myers Squibb
Princeton, NJ
About the Job
Working with Us
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
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. Read more: careers.bms.com/working-with-us .
Position Summary
The Senior Manager of Specialty Laboratory Quality will be responsible for conducting audits of clinical and nonclinical laboratories that perform bioanalytical and biomarker work under the Good Clinical Laboratory Practices (GCLP) guidelines as well as Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) regulations. They also act as a laboratory quality and compliance subject matter expert (SME) to key stakeholders in GCLP, GLP, GCP related areas.
Key Responsibilities:
+ Maintain an in-depth knowledge of governmental regulations that impact the research and development of medicines as well as the relevant Bristol-Myers Squibb Company policies and procedures associated with bioanalytical and biomarker analyses supporting clinical (GCLP and GCP) or nonclinical (GLP) research.
+ Act as an SME with key stakeholders and provide advice and counsel concerning GCLP, GLP and GCP regulatory requirements.
+ Conduct Quality System audits at various internal R&D sites/functional areas and external contract laboratories to assess compliance with governmental regulations, study protocols and established operating procedures.
+ Compile documentation in preparation for the audit. Conduct audit in accordance to the audit plan.
+ Prepare clear, accurate, and evidence-based audit reports to effectively communicate the audit findings.
+ 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.
+ Maintain the audit database. Lead or participate in cross-functional audits (domestic and international) with other auditing teams and/or with stakeholder involvement.
+ Conduct other audits or investigations of regulatory concern as directed by RDQ-NCQ management.
+ Lead NCQ project teams/initiatives and participate in RDQ & GQ enterprise projects/initiatives.
+ Assist in the preparation of departmental standard operating procedures.
+ Participate in the preparation and conduct of regulatory training given to personnel involved in the conduct of preclinical and/or clinical studies.
+ Lead or coordinate NCQ inspection readiness activities.
+ Coordinate/manage regulatory agency inspections (e.g., FDA) and associated activities.
+ Adherence and demonstration to BMS core behaviors with enhanced capabilities as a team player, mentor or model to others, and leadership potential.
Qualifications & Experience:
+ University graduate (science degree preferred)
+ At least 4 years' audit experience or experience in a highly regulated environment.
+ At least 6 years' experience in the biopharmaceutical industry or related technical field.
+ Daily collaboration and potential mentoring of other NCQ auditors in the preparation, conduct, reporting and follow-up of audits and inspections.
+ 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 NCQ management.
+ Collaboration with external colleagues and trade associations.
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 .
#LI-Hybrid
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol-Myers Squibb
Req Number: R1588930
Updated: 2025-03-04 05:25:06.098 UTC
Location: Princeton-NJ
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
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. Read more: careers.bms.com/working-with-us .
Position Summary
The Senior Manager of Specialty Laboratory Quality will be responsible for conducting audits of clinical and nonclinical laboratories that perform bioanalytical and biomarker work under the Good Clinical Laboratory Practices (GCLP) guidelines as well as Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) regulations. They also act as a laboratory quality and compliance subject matter expert (SME) to key stakeholders in GCLP, GLP, GCP related areas.
Key Responsibilities:
+ Maintain an in-depth knowledge of governmental regulations that impact the research and development of medicines as well as the relevant Bristol-Myers Squibb Company policies and procedures associated with bioanalytical and biomarker analyses supporting clinical (GCLP and GCP) or nonclinical (GLP) research.
+ Act as an SME with key stakeholders and provide advice and counsel concerning GCLP, GLP and GCP regulatory requirements.
+ Conduct Quality System audits at various internal R&D sites/functional areas and external contract laboratories to assess compliance with governmental regulations, study protocols and established operating procedures.
+ Compile documentation in preparation for the audit. Conduct audit in accordance to the audit plan.
+ Prepare clear, accurate, and evidence-based audit reports to effectively communicate the audit findings.
+ 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.
+ Maintain the audit database. Lead or participate in cross-functional audits (domestic and international) with other auditing teams and/or with stakeholder involvement.
+ Conduct other audits or investigations of regulatory concern as directed by RDQ-NCQ management.
+ Lead NCQ project teams/initiatives and participate in RDQ & GQ enterprise projects/initiatives.
+ Assist in the preparation of departmental standard operating procedures.
+ Participate in the preparation and conduct of regulatory training given to personnel involved in the conduct of preclinical and/or clinical studies.
+ Lead or coordinate NCQ inspection readiness activities.
+ Coordinate/manage regulatory agency inspections (e.g., FDA) and associated activities.
+ Adherence and demonstration to BMS core behaviors with enhanced capabilities as a team player, mentor or model to others, and leadership potential.
Qualifications & Experience:
+ University graduate (science degree preferred)
+ At least 4 years' audit experience or experience in a highly regulated environment.
+ At least 6 years' experience in the biopharmaceutical industry or related technical field.
+ Daily collaboration and potential mentoring of other NCQ auditors in the preparation, conduct, reporting and follow-up of audits and inspections.
+ 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 NCQ management.
+ Collaboration with external colleagues and trade associations.
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 .
#LI-Hybrid
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol-Myers Squibb
Req Number: R1588930
Updated: 2025-03-04 05:25:06.098 UTC
Location: Princeton-NJ
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
Source : Bristol Myers Squibb