Senior Specialist Compliance Process Excellence, Commercial Operations

Bristol Myers Squibb in Boudry, CH seeks a Senior Specialist for Compliance Process Excellence in Commercial Operations. The role focuses on GMP documentation, quality management, and inspection readiness.

This position is responsible for maintaining GMP compliance within the manufacturing environment. The specialist manages documentation, quality events, risk assessments, and inspection readiness. The role also supports deviation management, change control, and audit responses while contributing to continuous improvement efforts.

Responsibilities

• Create and update manufacturing GMP documentation, such as SOPs, forms, and logbooks.
• Manage the full lifecycle of documents to ensure ongoing compliance.
• Lead QMS actions from start to finish, including CAPA, proactive initiatives, and standalone actions.
• Manage Change Controls from initiation through closure.
• Address findings from self-inspections by initiating and owning necessary activities.
• Handle quality events that do not require root cause analysis.
• Manage deviations from creation through assessment.
• Participate in deviation investigations when required.
• Initiate Supplier Corrective Action Requests (SCARs).
• Engage in Communities of Practice (CoPs).
• Perform and maintain Manufacturing Risk Assessments.
• Conduct Data Integrity Risk Assessments (DIRA) and prepare summary reports.
• Support staff training on the defect library.
• Serve as the Manufacturing Single Point of Contact for inspection readiness.
• Contribute actively to manufacturing inspection-readiness activities.
• Follow up on responses to audit observations and inspection findings.
• Support local initiatives aimed at improving compliance, process effectiveness, and inspection readiness.

Requirements

• Bachelor’s degree in Life Sciences or a related field.
• 3-5 years of experience in GMP compliance.
• 3-5 years of experience in the pharmaceutical environment.
• Experience with GMP inspections and audits.
• Business-level proficiency in French and English.
• Strong collaboration and communication skills.

What the company offers

• A wide variety of competitive benefits, services, and programs.
• Opportunities to grow and thrive alongside high-achieving teams.
• A supportive culture that promotes global participation in clinical trials.

About the company

Bristol Myers Squibb is driven by a vision to transform patients’ lives through science. The company values passion, innovation, urgency, accountability, inclusion, and integrity. It recognizes the importance of balance and flexibility in the work environment, offering challenging and meaningful work that has the potential to change patients' lives.

• Challenging, meaningful, life-changing work that transforms patients' lives.
• Vision to transform patients’ lives through science.
• Shared values of passion, innovation, urgency, accountability, inclusion and integrity.
• Recognition of the importance of balance and flexibility in the work environment.