Manager Bioanalysis - GLP Lab Compliance
Bristol Myers Squibb
4 hours ago
Remote friendly (Princeton, NJ)
United States
Operations
Position Summary
- The Manager, Lab Compliance (GLP & Bioanalysis) ensures quality oversight and compliance leadership for GLP and bioanalytical laboratory activities supporting nonclinical and clinical development, including internal/external CRO services, vendor qualification, performance monitoring, audit readiness, regulatory inspections, and continuous improvement.
Responsibilities
- Partner with Bioanalytical Scientists to set quality oversight strategy for GLP/bioanalytical activities (toxicology, PK, 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 (qualification, audits, compliance monitoring).
- Support regulatory inspection/audit hosting as the primary Bioanalytical Lead contact.
- Ensure scientific integrity and regulatory compliance for method development, validation, and sample analysis (e.g., LC-MS/MS, ELISA, qPCR).
- Ensure study protocols, reports, and regulatory submissions adhere to GLP.
- Drive resolution of deviations, CAPAs, and change controls across internal and external labs.
- Implement documentation and data integrity practices across testing sites (including archiving and audit readiness).
- Collaborate with procurement and quality to ensure CRO contracts include compliance expectations and deliverables.
- Support structured performance dashboards, risk trending analytics, and governance forums.
- Partner with Bioanalysis, Nonclinical Safety, Clinical Pharmacology, Clinical Pharmacometrics, Translational Science, Clinical Development, Regulatory Affairs, and Lab Quality Assurance.
- Lead training/competency programs; mentor and develop junior staff.
- Lead change initiatives for GLP modernization, digital transformation, or global quality harmonization.
Qualifications
- Bachelor’s degree in a relevant scientific discipline required; MS/PharmD/PhD strongly preferred.
- 4–5 years of lab compliance, bioanalysis, or related experience in pharma/biotech/medical devices.
- Strong knowledge of GLP and bioanalytical laboratory compliance and global regulations, including GLP (OECD, ICH M10), GCP (ICH E6), GMP (21 CFR Parts 210/211), GDP (Good Documentation Practice), FDA Quality System Regulation (21 CFR Part 58), IVDR (EU), and data integrity (ALCOA+).
- Experience with vendor/CRO management, audit/inspection readiness, and regulatory submissions.
- Experience with digital quality systems (LIMS/ELN, eQMS, audit-management platforms, data integrity tools).
- Ability to facilitate risk assessments and risk-based sampling/testing plans.
- Preferred certifications: RQAP-GLP, ASQ CQA, or other recognized compliance qualifications.
- Travel: up to 20%.
Benefits (explicitly stated)
- Health coverage (medical, pharmacy, dental, vision); wellbeing support; financial wellbeing and protection (401(k), disability, life/accident/supplemental insurance, business travel protection, legal support, survivor support).
- Paid Time Off: flexible/unlimited time off for US exempt employees (with manager approval) and 11 paid national holidays; 160 hours annual paid vacation for certain roles, plus national holidays and optional holidays.
- Additional eligibility-based time off may include paid sick time, volunteer days, summer hours flexibility, leaves of absence, and annual Global Shutdown.
Compensation (explicitly stated)
- Princeton, NJ, US: $107,630–$130,419 (plus potential incentive cash/stock based on eligibility).
Application instructions (explicitly stated)
- If the role doesn’t perfectly line up with your resume, encouraged to apply anyway.
- The Manager, Lab Compliance (GLP & Bioanalysis) ensures quality oversight and compliance leadership for GLP and bioanalytical laboratory activities supporting nonclinical and clinical development, including internal/external CRO services, vendor qualification, performance monitoring, audit readiness, regulatory inspections, and continuous improvement.
Responsibilities
- Partner with Bioanalytical Scientists to set quality oversight strategy for GLP/bioanalytical activities (toxicology, PK, 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 (qualification, audits, compliance monitoring).
- Support regulatory inspection/audit hosting as the primary Bioanalytical Lead contact.
- Ensure scientific integrity and regulatory compliance for method development, validation, and sample analysis (e.g., LC-MS/MS, ELISA, qPCR).
- Ensure study protocols, reports, and regulatory submissions adhere to GLP.
- Drive resolution of deviations, CAPAs, and change controls across internal and external labs.
- Implement documentation and data integrity practices across testing sites (including archiving and audit readiness).
- Collaborate with procurement and quality to ensure CRO contracts include compliance expectations and deliverables.
- Support structured performance dashboards, risk trending analytics, and governance forums.
- Partner with Bioanalysis, Nonclinical Safety, Clinical Pharmacology, Clinical Pharmacometrics, Translational Science, Clinical Development, Regulatory Affairs, and Lab Quality Assurance.
- Lead training/competency programs; mentor and develop junior staff.
- Lead change initiatives for GLP modernization, digital transformation, or global quality harmonization.
Qualifications
- Bachelor’s degree in a relevant scientific discipline required; MS/PharmD/PhD strongly preferred.
- 4–5 years of lab compliance, bioanalysis, or related experience in pharma/biotech/medical devices.
- Strong knowledge of GLP and bioanalytical laboratory compliance and global regulations, including GLP (OECD, ICH M10), GCP (ICH E6), GMP (21 CFR Parts 210/211), GDP (Good Documentation Practice), FDA Quality System Regulation (21 CFR Part 58), IVDR (EU), and data integrity (ALCOA+).
- Experience with vendor/CRO management, audit/inspection readiness, and regulatory submissions.
- Experience with digital quality systems (LIMS/ELN, eQMS, audit-management platforms, data integrity tools).
- Ability to facilitate risk assessments and risk-based sampling/testing plans.
- Preferred certifications: RQAP-GLP, ASQ CQA, or other recognized compliance qualifications.
- Travel: up to 20%.
Benefits (explicitly stated)
- Health coverage (medical, pharmacy, dental, vision); wellbeing support; financial wellbeing and protection (401(k), disability, life/accident/supplemental insurance, business travel protection, legal support, survivor support).
- Paid Time Off: flexible/unlimited time off for US exempt employees (with manager approval) and 11 paid national holidays; 160 hours annual paid vacation for certain roles, plus national holidays and optional holidays.
- Additional eligibility-based time off may include paid sick time, volunteer days, summer hours flexibility, leaves of absence, and annual Global Shutdown.
Compensation (explicitly stated)
- Princeton, NJ, US: $107,630–$130,419 (plus potential incentive cash/stock based on eligibility).
Application instructions (explicitly stated)
- If the role doesn’t perfectly line up with your resume, encouraged to apply anyway.