Quality Manager - Sterile Manufacturing

To reinforce the Quality organization of a sterile manufacturing site, we are looking for a Quality Manager able to provide immediate, hands-on QA support on qualification, validation, supplier qualification, and GMP technical systems.

Key Responsibilities :

QA Oversight – Qualification & Validation

• QA support for equipment, utilities (HVAC, gases), and computerized systems qualification
• Review and approval of protocols, reports, and deviations
• Application of validation lifecycle principles
• QA support to aseptic process validation activities

Material & Supplier Qualification

• Establish and maintain material qualification processes (raw materials, primary packaging, consumables)
• Risk-based supplier qualification and oversight
• Management of supplier changes, deviations, and quality notifications
• Support to Quality Agreements management

QA Oversight – Maintenance & Calibration

• QA oversight of maintenance and calibration systems for GMP-critical equipment and utilities
• Review and approval of plans, records, deviations, and change controls
• Ensure GMP compliance and data integrity related to calibration status

Operational QA Support

• Deviation, investigation, CAPA, and change control management
• Technical risk assessments (equipment, utilities, materials)
• SOP updates and remediation activities linked to technical systems

Profile Requirements :

Education & Experience

• Scientific or Engineering degree (Pharmacy, Chemistry, Life Sciences, Engineering)
• 3–8 years of QA experience in GMP pharmaceutical environments
• Proven experience in sterile manufacturing
• Hands-on experience with qualification, validation, and technical GMP systems

Technical Expertise

• Strong knowledge of EU GMP, Annex 1 and Annex 15
• Solid understanding of validation lifecycle principles
• Experience in supplier qualification and quality oversight
• Strong knowledge of GMP maintenance and calibration requirements

Key Competencies

• Pragmatic, solution-oriented mindset
• Autonomous with fast integration capability
• Strong documentation and communication skills
• High GMP awareness and attention to detail

Position to be filled ASAP

Compensation starting from €40,000 gross per year

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