Quality Assurance Manager

SCO; Crissier; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

SCO is looking for a QA Manager / Responsible Person (RP) to support our growing portfolio of biotech clients across Europe. The role combines GDP (and GMP) quality management & compliance, Responsible Person activities, and client-facing consulting.

The candidate will provide QA oversight for GDP/GMP operations, audits, CAPAs, QMS design, and supplier oversight, and act as RP for Swiss and/or European wholesale distribution as applicable.

Qualifikationen

• Degree in pharmacy or life sciences or related field.
• Experience in pharmaceutical QA, GMP/GDP, wholesale distribution or GxP environments.
• Strong understanding of EU/Swiss GMP and GDP requirements.

Aufgaben

• Provide QA oversight for GDP and GMP operations, distributors, suppliers, 3PLs and service providers.
• Support clients with QMS design, SOPs, quality agreements, risk assessments and compliance.
• Lead or support GMP and GDP audits and inspections, CAPA management and follow-up.
• Oversee product distribution quality, temperature-controlled shipments, deviations, complaints, recalls and change controls.
• Support EU market entry and launch readiness activities, including RP interfaces.

Kenntnisse

QA Management

GxP Compliance

Stakeholder Management

Audits & CAPAs

Quality Agreements

Ausbildung

Pharmacy or Life Sciences degree

Tools

QMS Software

Jobbeschreibung

SCO is looking for a QA Manager / Responsible Person (RP) to support our growing portfolio of biotech clients across Europe.

The role combines GDP (and GMP) quality management & compliance, Responsible Person activities, and client-facing consulting.

Key Responsibilities

• Provide QA oversight for external GDP (and GMP) operations, distribution networks, suppliers, 3PLs and service providers.
• Support clients with QMS design and implementation, SOPs, quality agreements, risk assessments and compliance assessments.
• Lead or support GMP and GDP audits and inspections, including preparation, execution and follow-up of CAPAs.
• Provide quality oversight for product distribution, temperature-controlled shipments, deviations, complaints, recalls, returns and change controls.
• Support EU market entry and launch readiness activities, including MIA/WDA and QP/RP interfaces.
• Act as Responsible Person (RP) for Swiss and/or European wholesale distribution activities, as applicable.
• Contribute to the development of SCO's QA, GMP/GDP and RP consulting services.

Profile

• Degree in pharmacy, life sciences or a related scientific discipline.
• 7+ years of experience in pharmaceutical QA, GMP/GDP, wholesale distribution or related GxP environments.
• Solid understanding of EU/Swiss GMP and GDP requirements.
• Experience with QMS, audits, quality agreements, supplier oversight and risk management.
• RP experience/qualification is highly desirable.
• Strong communication and stakeholder-management skills, with the ability to work independently in a consulting environment.
• Fluent in English and French; German is an advantage.