External QA Manager – Biologics & CMO Oversight

Pharmanovia; Breda; Ibrido; EUR 90.000 - 130.000; Tempo pieno

Vantaggi offerti da questo lavoro

Bonus

Pension scheme

Hybrid working

Holidays

Employee recognition awards

Social events

Descrizione del lavoro

Pharmanovia in Breda (Netherlands) seeks an experienced External Quality Assurance Manager to oversee QA for external manufacturing partners, including CMOs/CDMOs, ensuring GMP/GDP compliance and robust quality systems.

Your role will lead quality agreements, audit programs, CAPAs and change controls for biological products and biosimilars, partnering with global teams to safeguard product quality and patient safety.

Competenze

• Bachelor's degree in pharmaceutical sciences or equivalent; postgraduate degree or diploma is a bonus.
• Experience with GMP, EU GMDP requirements and ICH guidance applicable to biological products, including Q5 guidance.
• Experience in quality oversight of biosimilars, biological drug substance and product, including aseptic processing and cold-chain distribution.
• Experience in preparing and negotiating Quality Technical Agreements and facilitating OOS/root cause analysis.
• Ability to plan and execute external audits of CMOs/CDMOs and manage CAPAs.

Mansioni

• Write, review and negotiate Quality Agreements to document responsibilities.
• Plan and execute external audits; manage audit KPIs.
• Provide quality oversight of CMO deviations, change controls and complaints.
• Lead investigations and escalate as required.
• Support technology transfer and process validation of biological products.
• Identify and communicate quality risks to project managers.

Conoscenze

GMP knowledge

ICH guidance familiarity

Quality communication

Independence and initiative

Cross-functional collaboration

Formazione

Bachelor’s degree in pharmaceutical sciences

Postgraduate degree or diploma

Strumenti

Quality Management Systems

Audit management tools

Descrizione del lavoro

Pharmanovia in Breda (Netherlands) seeks an experienced External Quality Assurance Manager to oversee QA for external manufacturing partners, including CMOs/CDMOs, ensuring GMP/GDP compliance and robust quality systems.

Your role will lead quality agreements, audit programs, CAPAs and change controls for biological products and biosimilars, partnering with global teams to safeguard product quality and patient safety.