Manager Bioanalysis - GLP Lab Compliance
Bristol Myers Squibb, Princeton, NJ, United States
Position Summary
The Manager, Lab Compliance (GLP & Bioanalysis) ensures quality oversight and compliance leadership for all GLP and bioanalytical laboratory activities supporting nonclinical and clinical development. The role guarantees robust, compliant lab services and data integrity across internal and external CRO laboratories, including vendor qualification and performance monitoring. Responsibilities include audit readiness, supporting regulatory inspections, continuous improvement initiatives, and compliance with bioanalysis AI/automation and risk‑based oversight frameworks.
Position Responsibilities
Partner with Bioanalytical Scientists to optimize strategic direction for quality oversight of GLP and bioanalytical activities, including toxicology, PK, and ADA biomarkers.
Maintain GLP quality systems, SOPs, and training programs.
Ensure compliance with global regulatory standards (FDA, EMA, OECD, ICH) and internal quality requirements.
Partner with Lab Quality for risk‑based oversight of internal labs and external CROs, including qualification, audits, and compliance monitoring.
Serve as the primary Bioanalytical Lead contact for regulatory inspections and audit hosts.
Ensure scientific integrity and regulatory compliance in method development, validation, and sample analysis for bioanalytical studies such as LC‑MS/MS, ELISA, qPCR.
Ensure study protocols, reports, and regulatory submissions adhere to GLP standards.
Drive resolution of deviations, CAPAs, and change controls across internal and external labs, ensuring timely corrective actions.
Implement robust documentation and data integrity practices across all testing sites, including archiving and audit readiness.
Collaborate with procurement and quality teams to ensure CRO contracts include clear compliance expectations and deliverables.
Support enhancements of structured performance dashboards, risk trending analytics, and formal governance forums.
Partner with cross‑functional teams: Bioanalysis, Nonclinical Safety, Clinical Pharmacology, Clinical Pharmacometrics, Translational Science, Clinical Development, Regulatory Affairs, and Lab Quality Assurance.
Lead organizational change initiatives related to GLP modernization, digital transformation, or global quality harmonization.
Lead training and competency programs for laboratory staff and stakeholders.
Mentor and develop junior staff, fostering a culture of quality and compliance.
Qualifications & Experience
Degree Requirements:
Bachelor’s degree in a relevant scientific discipline required; advanced degree (MS, PharmD, PhD) strongly preferred.
Minimum 4‑5 years of lab compliance, bioanalysis, or related experience in pharma, biotech, or medical device industries.
Experience managing global compliance programs, CRO governance, and digital quality system implementation strongly preferred.
Strong knowledge of GLP, GCP, GMP, GDP, FDA Quality System Regulation, IVDR, and data integrity principles (ALCOA+).
Experience with vendor/CRO management, audit/inspection readiness, and regulatory submissions.
Experience with digital quality systems such as LIMS/ELN, eQMS, audit‑management platforms, and data integrity tools.
Ability to facilitate risk assessments, enterprise risk mitigation strategies, and risk‑based sampling/testing plans.
Preferred certifications: RQAP‑GLP, ASQ CQA, or other recognized compliance qualifications.
Strong communication and collaboration skills; ability to translate scientific and compliance concepts into clear, actionable insights for cross‑functional teams.
Demonstrated influence and decision‑making ability in cross‑functional teams to balance innovation, compliance, and enterprise impact.
Travel
Up to 20% travel.
Compensation Overview
Princeton, NJ – US$107,630 – $130,419 per year. Additional incentive cash and stock opportunities (based on eligibility) may be available.
Benefits
Health coverage (medical, pharmacy, dental, vision). Well‑being support programs and employee assistance programs. Financial protection such as 401(k), disability, life insurance, and related benefits.
Equal Employment Opportunity (EEO) Statement
Broscys BMS is an Equal Opportunity Employer. We celebrate a diverse workforce and encourage employees with disabilities, including accommodations and reasonable adjustments.
Data Protection
Payments or financial information will never be requested during the application or recruitment process. All personal data are protected in accordance with applicable privacy policies and regulations.
Legal Notice
In California residents, additional information applies. For data protection inquiries, visit the appropriate resource.
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The Manager, Lab Compliance (GLP & Bioanalysis) ensures quality oversight and compliance leadership for all GLP and bioanalytical laboratory activities supporting nonclinical and clinical development. The role guarantees robust, compliant lab services and data integrity across internal and external CRO laboratories, including vendor qualification and performance monitoring. Responsibilities include audit readiness, supporting regulatory inspections, continuous improvement initiatives, and compliance with bioanalysis AI/automation and risk‑based oversight frameworks.
Position Responsibilities
Partner with Bioanalytical Scientists to optimize strategic direction for quality oversight of GLP and bioanalytical activities, including toxicology, PK, and ADA biomarkers.
Maintain GLP quality systems, SOPs, and training programs.
Ensure compliance with global regulatory standards (FDA, EMA, OECD, ICH) and internal quality requirements.
Partner with Lab Quality for risk‑based oversight of internal labs and external CROs, including qualification, audits, and compliance monitoring.
Serve as the primary Bioanalytical Lead contact for regulatory inspections and audit hosts.
Ensure scientific integrity and regulatory compliance in method development, validation, and sample analysis for bioanalytical studies such as LC‑MS/MS, ELISA, qPCR.
Ensure study protocols, reports, and regulatory submissions adhere to GLP standards.
Drive resolution of deviations, CAPAs, and change controls across internal and external labs, ensuring timely corrective actions.
Implement robust documentation and data integrity practices across all testing sites, including archiving and audit readiness.
Collaborate with procurement and quality teams to ensure CRO contracts include clear compliance expectations and deliverables.
Support enhancements of structured performance dashboards, risk trending analytics, and formal governance forums.
Partner with cross‑functional teams: Bioanalysis, Nonclinical Safety, Clinical Pharmacology, Clinical Pharmacometrics, Translational Science, Clinical Development, Regulatory Affairs, and Lab Quality Assurance.
Lead organizational change initiatives related to GLP modernization, digital transformation, or global quality harmonization.
Lead training and competency programs for laboratory staff and stakeholders.
Mentor and develop junior staff, fostering a culture of quality and compliance.
Qualifications & Experience
Degree Requirements:
Bachelor’s degree in a relevant scientific discipline required; advanced degree (MS, PharmD, PhD) strongly preferred.
Minimum 4‑5 years of lab compliance, bioanalysis, or related experience in pharma, biotech, or medical device industries.
Experience managing global compliance programs, CRO governance, and digital quality system implementation strongly preferred.
Strong knowledge of GLP, GCP, GMP, GDP, FDA Quality System Regulation, IVDR, and data integrity principles (ALCOA+).
Experience with vendor/CRO management, audit/inspection readiness, and regulatory submissions.
Experience with digital quality systems such as LIMS/ELN, eQMS, audit‑management platforms, and data integrity tools.
Ability to facilitate risk assessments, enterprise risk mitigation strategies, and risk‑based sampling/testing plans.
Preferred certifications: RQAP‑GLP, ASQ CQA, or other recognized compliance qualifications.
Strong communication and collaboration skills; ability to translate scientific and compliance concepts into clear, actionable insights for cross‑functional teams.
Demonstrated influence and decision‑making ability in cross‑functional teams to balance innovation, compliance, and enterprise impact.
Travel
Up to 20% travel.
Compensation Overview
Princeton, NJ – US$107,630 – $130,419 per year. Additional incentive cash and stock opportunities (based on eligibility) may be available.
Benefits
Health coverage (medical, pharmacy, dental, vision). Well‑being support programs and employee assistance programs. Financial protection such as 401(k), disability, life insurance, and related benefits.
Equal Employment Opportunity (EEO) Statement
Broscys BMS is an Equal Opportunity Employer. We celebrate a diverse workforce and encourage employees with disabilities, including accommodations and reasonable adjustments.
Data Protection
Payments or financial information will never be requested during the application or recruitment process. All personal data are protected in accordance with applicable privacy policies and regulations.
Legal Notice
In California residents, additional information applies. For data protection inquiries, visit the appropriate resource.
#J-18808-Ljbffr