Manager Bioanalysis - GLP Lab Compliance

Bristol Myers Squibb • Princeton, NJ

4d • Hybrid

About The Position

The Manager, Lab Compliance (GLP & Bioanalysis) ensures quality oversight and compliance leadership for all GLP and bioanalytical laboratory activities supporting nonclinical and clinical development. This role ensures robust, compliant lab services and data integrity across internal and external CROs laboratories, including vendor qualification and performance monitoring. The position ensures audit readiness, global regulatory inspections, and continuous improvement initiatives, partnering cross-functionally to support the organization’s pipeline and business objectives. Additionally, this role supports compliance to bioanalysis AI/automation, risk‑based oversight frameworks, and enterprise‑level quality governance to meet evolving global expectations.

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.
• Strong knowledge in GLP and bioanalytical laboratory compliance and global quality standards and 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 (In Vitro Diagnostic Regulation) for EU compliance 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.
• Skilled in translating scientific and compliance concepts into clear, actionable insights for cross-functional teams.
• Builds partnerships across internal and external stakeholders in matrixed environments to drive alignment and shared success.
• Demonstrates personal accountability and ability to facilitate collaboration in cross functional teams in making timely, high-quality regulatory decisions that balance innovation, compliance, and enterprise impact.

Nice To Haves

• Experience managing global compliance programs, CRO governance, and digital quality system implementation strongly preferred.
• Preferred certifications: RQAP‑GLP, ASQ CQA, or other recognized compliance qualifications.

Responsibilities

• GLP & Bioanalysis Compliance Oversight 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.
• Support the primary Bioanalytical Lead contact for regulatory inspections and audit hosts.
• Ensure scientific integrity and regulatory compliance with regards method development, validation, and sample analysis for bioanalytical studies (e.g., 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 and effective 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 Bioanalysis, Nonclinical Safety, Clinical Pharmacology, Clinical Pharmacometrics, Translational Science, Clinical Development, Regulatory Affairs, and Lab Quality Assurance teams.
• Experience leading 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.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
• All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees