Senior Specialist Compliance Process Excellence, Commercial Operations

Working with Us Challenging. Meaningful. Life-changing. Those aren’t 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. You’ll 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: careers.bms.com/working-with-us.

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

If you come across a role that intrigues you but doesn’t 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.

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 accommodations/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 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: 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 you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. 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.

R1605097 : Senior Specialist Compliance Process Excellence, Commercial Operations