Senior QA Operations Manager GMP/GDP

JCW Group; Basel-Landschaft; Vor Ort; CHF 110.000 - 140.000; Vollzeit

Zusammenfassung

JCW Group in Basel region seeks a Senior QA Operations Manager to provide QA oversight across CDMOs throughout the product lifecycle, ensuring adherence to cGMP and GDP. You will lead investigations, CAPA, and change controls, while drafting GMP/GDP agreements and guiding the CMC team.

The role requires 3–6 years in QA for drug substance/product, strong regulatory knowledge, and the ability to work fast-paced environments with internal/external stakeholders.

Qualifikationen

• Master's degree in Pharmacy, Chemistry or related discipline.
• 3–6 years of QA experience in drug substance and/or drug product.
• Experience with CMOs and external manufacturing partners.
• Strong knowledge of cGMP and GDP.

Aufgaben

• Provide QA oversight for drug substance and drug product activities at CMOs throughout the product lifecycle.
• Lead management of deviations, OOS results, complaints and investigations, including CAPA definition and follow-up.
• Support release of APIs, bulk products and investigational medicinal products, including batch record review and change control assessment.
• Draft and manage GMP/GDP agreements with CMOs.
• Represent QA topics within the CMC team and write/approve SOPs.
• Review and monitor CMO quality KPIs; act as QA contact for external manufacturers and internal stakeholders.

Kenntnisse

QA management

GMP/GDP knowledge

Deviations & CAPA

CMO partnerships

SOP writing

Regulatory compliance

Stakeholder management

External manufacturing

Ausbildung

Master's degree in Pharmacy, Chemistry or related discipline

Jobbeschreibung

Senior QA Operations Manager GMP/GDP - Pharma | Basel Region

• Start: November 2026, early December at the latest
• Duration: 12 months
• On-site: Minimum 3 days per week, with the remaining time remote
• Provide QA oversight for drug substance and drug product activities at CMOs throughout the product lifecycle
• Lead the management of deviations, OOS results, complaints and investigations, including CAPA definition and follow-up
• Support the release of APIs, bulk products and investigational medicinal products, including batch record review and change control assessment
• Draft and manage GMP/GDP agreements with CMOs
• Represent QA topics within the CMC team
• Write and approve SOPs
• Review and monitor CMO quality KPIs
• Act as a key QA contact for external manufacturing partners and internal stakeholders
• Master's degree in Pharmacy, Chemistry or a related scientific discipline
• 3-6 years of experience in QA within drug substance and/or drug product
• Ideally, experience across QC, analytical or production activities in addition to QA
• Proven experience working with external contract manufacturers / CMOs
• Strong knowledge of cGMP and GDP requirements
• Independent, assertive and comfortable working in a fast-paced project environment
• German or French would be an advantage