Manager Bioanalysis GLP Lab Compliance

Working with Us
Challenging. Meaningful. Life-changing. Those arent 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. Youll get the chance to grow and thrive through opportunities uncommon in scale and scope alongside high-achieving teams. 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: 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. 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 organizations pipeline and business objectives. Additionally this role supports compliance to bioanalysis AI/automation riskbased oversight frameworks and enterpriselevel quality governance to meet evolving global expectations.

Position 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.

Cross-Functional Collaboration

• Partner with Bioanalysis Nonclinical Safety Clinical Pharmacology Clinical Pharmacometrics Translational Science Clinical Development Regulatory Affairs and Lab Quality Assurance teams.

Continuous Improvement & Training

• 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.

Qualifications & Experience

Degree Requirements:Bachelors degree in a relevant scientific discipline required; advanced degree (MS PharmD PhD) strongly preferred.

Experience Requirements:

• 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.

Key Competency Requirements

• 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 riskbased sampling/testing plans.

• Preferred certifications: RQAPGLP ASQ CQA or other recognized compliance qualifications.

• Communication & Collaboration: 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.

• Influence & Decision Making: 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.

Travel: Up to 20%

#LI-Hybrid

If you come across a role that intrigues you but doesnt 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.

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job such as required skills where the job is performed the employees work schedule job-related knowledge and experience. Final individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits please visit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:

• 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.

*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours depending on the nature of their work and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors leased workers and other service providers are not eligible to participate in the program.

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 a supportive culture promoting global participation 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 an 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.

Supporting People with Disabilities

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 . Visit to access our complete Equal Employment Opportunity statement.

Candidate Rights

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: Protection

We will never request payments financial information or social security numbers during our application or recruitment process. Learn more about protecting yourself at data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If you believe that the job posting is missing information required by local law or incorrect in any way please contact BMS at . Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.