Quality Operations Leader, GMP/GDP Release & Compliance

Bristol Myers Squibb; Boudry; Vor Ort; CHF 150.000 - 190.000; Vollzeit

Zusammenfassung

Bristol Myers Squibb is seeking a Senior Manager Quality Operations, Delegate RP/FvP, to lead and sustain the Quality Management System in our Boudry operations. You will ensure GMP/GDP compliance for manufacturing and distribution and technically release batches in line with applicable regulations and internal guidelines.

In this role you will oversee QMS improvements, supplier qualifications, recalls, CAPA, and audits, while collaborating with local authorities and cross-functional teams to

Qualifikationen

• Extensive experience with GMP and GDP in pharmaceutical manufacturing and distribution.
• Familiarity with Swiss regulatory requirements and international guidelines.
• Proven ability to release batches and supervise quality activities.
• Experience in maintaining and improving the Quality Management System (QMS).
• Strong analytical and problem-solving skills for CAPA and deviations.

Aufgaben

• Maintain and improve the Quality Management System to ensure ongoing compliance.
• Authority to issue directives within the area of responsibility.
• Ensure GMP/GDP compliance for externally manufactured and traded products.
• Perform supplier qualification and maintain Approved Supplier List activities.
• Coordinate recalls and support Health Authority inspections and audits.
• Lead self-inspections and implement corrective actions when required.
• Author and review SOPs and batch release documentation.
• Manage customer/technical complaints as needed.
• Apply Quality Risk Management to assess and mitigate product quality risks.
• Collect KPIs to evaluate QMS effectiveness on a periodic basis.
• Support CAPA implementation with RP/FvP collaboration.
• Participate in training events and cross-site quality initiatives.

Kenntnisse

Quality Management

GMP/GDP knowledge

Regulatory compliance

Leadership

Documentation control

Jobbeschreibung

Bristol Myers Squibb is seeking a Senior Manager Quality Operations, Delegate RP/FvP, to lead and sustain the Quality Management System in our Boudry operations. You will ensure GMP/GDP compliance for manufacturing and distribution and technically release batches in line with applicable regulations and internal guidelines.

In this role you will oversee QMS improvements, supplier qualifications, recalls, CAPA, and audits, while collaborating with local authorities and cross-functional teams to