Senior GMP Process Excellence & Compliance Specialist

Bristol-Myers Squibb Co; Boudry; On-site; CHF 120,000 - 150,000; Full time

Job summary

Bristol Myers Squibb in Switzerland is seeking a Senior Specialist Process Excellence Compliance to lead Quality Events management and support inspection readiness and regulatory audits. You will own quality events (CAPAs, change controls, complaints, deviations), maintain GMP documents, and ensure timely approvals through the document system.

The role requires a life sciences degree, 3–5 years GMP compliance experience, knowledge of regulatory requirements, and strong communication, analytical,

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 and responses drafting.
• Knowledge of pharmaceutical facilities and OSd processes.
• Strong communication skills and cross-functional workability.
• Business level in French and English.

Responsibilities

• Own quality Event and associated actions (CAPAs, Change Controls, complaints and deviations).
• Author and maintain GMP documentation (SOPs, specifications, forms, logbooks).
• Manage approval flow within electronic document system and coordinate stakeholders.
• 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.

Skills

Verbal communication

Written communication

Analytical thinking

Problem solving

Influencing

Deductive reasoning

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences or related field

Job description

Bristol Myers Squibb in Switzerland is seeking a Senior Specialist Process Excellence Compliance to lead Quality Events management and support inspection readiness and regulatory audits. You will own quality events (CAPAs, change controls, complaints, deviations), maintain GMP documents, and ensure timely approvals through the document system.

The role requires a life sciences degree, 3–5 years GMP compliance experience, knowledge of regulatory requirements, and strong communication, analytical,