Senior Specialist Compliance Process Excellence, Commercial Operations

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Ensures GMP compliance within Manufacturing by owning documentation, quality events, risk assessments, and inspection readiness activities. The role supports deviation management, change control and audit responses while contributing to defect library training and Communities of Practice. Through hands-on execution and collaboration, the position supports continuous improvement and sustained regulatory compliance.

Duties/Responsibilities

GMP Manufacturing Documentation & Training

• Author and maintain manufacturing GMP documentation, including SOPs, forms, and logbooks
• Act as document owner, ensuring lifecycle management and compliance

Manufacturing Quality Events & Compliance Processes

• Initiate and own activities from initiation to closure for:
• Actions coming form the QMS (e.g. CAPA, Proactive initiatives, standalone actions, Supplemental Actions, Change Action...)
• Change Controls
• Findings arising from self-inspections
• Quality event without root cause analysis
• Initiate and own deviations from creation through deviation assessment
• Participate to deviation investigation when needed
• Initiate Supplier Corrective Action Requests (SCARs)
• Participate to Communities of Practice (CoPs)

Risk Management

• Own, perform, and maintain risk assessments, including:
• Manufacturing Risk Assessments

Data Integrity Risk Assessments (DIRA) and associated summary reports

Defect library

• Participate to staff training to the defect library

Audit & Inspection Readiness

• Act as Manufacturing SPoC for inspection readiness.
• Actively contribute to manufacturing inspection-readiness
• Continue to responses coming from audit observations and inspection findings

Continuous Improvement

• Support local continuous improvement initiatives related to compliance, process effectiveness, and inspection readiness

Qualifications

• Bachelor’s degree in Life Sciences or related field
• 3-5 years in GMP compliance
• Good collaboration and communication skills
• 3-5 years of experience in pharmaceutical environment
• Business Level in French and English
• Experience in GMP inspections and audits

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only:  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/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If this posting is missing required information required by local law or incorrect, contact BMS at TAEnablement@bms.com with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1605097 : Senior Specialist Compliance Process Excellence, Commercial Operations