Senior Specialist Process Excellence

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.

The Senior Specialist Process Excellence Compliance contributes to the PU compliance excellence through the management of Quality Events and contributions to inspection readiness and regulatory audits.

Duties/Responsibilities

• Own quality Event and associated actions (eg: CAPAs, Change Controls, complaints and deviations).
• Author and maintain GMP documentation (including SOP, specifications, working practices, Forms and logbooks). Follow up approval flow within electronic documentations system and facilitate all stakeholders input to ensure documents are updated and approved in a timely manner
• Contribute to inspection readiness and regulatory audits.
• Support root cause analysis.
• Contribute to quality KPI adherence.
• Perform and/or own impact assessments and risk evaluations.
• Drive local continuous improvement and site initiatives
• Participate in compliance boards and forums.
• This job description is not intended to be exhaustive; additional duties and responsibilities may be assigned as needed to meet business requirements

Qualifications

• Bachelor's degree in Life Sciences or related field.
• 3-5 years' experience in GMP compliance.
• Knowledge of regulatory requirements and audit processes.
• Experienced in Health Authority inspections (preparation, process, presentations, responses drafting, etc.).
• Knowledge of pharmaceutical facilities, manufacturing, and laboratory systems and processes especially in Oral Solid Dosage form (OSD).
• Well-developed ability to constructively work across functional areas and levels to achieve results.
• Strong verbal and written communication skills.
• Strong analytical, problem solving, influential and deductive skills.
• Capability to work with short deadlines and simultaneous activities.
• Excellent organizational and project management skills.
• Business Level in French and English.

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.