Senior QA Ops Manager, GMP/GDP — Hybrid (Pharma)

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

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.