Senior Quality Operations Leader (RP/FvP, GMP/GDP)

Bristol-Myers Squibb Co; Boudry; Vor Ort; CHF 150.000 - 210.000; Vollzeit

Zusammenfassung

Bristol Myers Squibb is seeking a Senior Manager Quality Operations, Delegate RP/FvP, to oversee the Quality Management System for Swiss GMP/GDP compliance. The role focuses on batch release, risk management, CAPA, and regulatory inspections, with ultimate responsibility for product quality and regulatory adherence.

The position requires a Master’s or higher degree in a related field, extensive pharma quality experience, and fluency in English, with additional French/German preferred.

Qualifikationen

• Fluent English; strong leadership and strategic thinking required.
• Experience with cGMP, GDP, PIC/S and ICH guidelines in a regulated pharma environment.
• Previous Responsible Person (FvP) exposure or release experience is strongly preferred.

Aufgaben

• Maintain and continuously improve the Quality Management System to ensure legal compliance.
• Release non-ready-to-use and ready-to-use medicinal products in accordance with GMP/GDP and internal procedures.
• Lead QA activities, CAPA management, and risk assessments to maintain product quality.
• Coordinate recalls, supplier qualifications, and audits with RP/FvP oversight.
• Support inspections, audits, and ongoing professional development in GMP/GDP topics.

Kenntnisse

English fluency

Leadership

Strategic thinking

Analytical skills

Negotiation

Problem solving

Ausbildung

Pharmacy or related degree

Tools

SAP

Veeva

Electronic Document Management Systems

Jobbeschreibung

Bristol Myers Squibb is seeking a Senior Manager Quality Operations, Delegate RP/FvP, to oversee the Quality Management System for Swiss GMP/GDP compliance. The role focuses on batch release, risk management, CAPA, and regulatory inspections, with ultimate responsibility for product quality and regulatory adherence.

The position requires a Master’s or higher degree in a related field, extensive pharma quality experience, and fluency in English, with additional French/German preferred.