QA Manager; QP

Position: QA Manager (QP)
Location: Town of Belgium

As QA Manager & Qualified Person (QP), you will be responsible for the release of Raw Material for Magistral Preparation, clinical and commercial batches and overseen the entire pharmaceutical Quality Management System (QMS) at the site. Acting as astrategic leader, this role is key in establishing, maintaining, and strengthening a robust quality culture as the company transitions to full GMPoperations.

In this position, youwill provide oversight of QA, QC, and GMP compliance activities, ensuring thatall products meet national and European regulatory requirements. You will alsodrive quality and compliance initiatives throughout the product lifecycle,including QMS implementation, audits, complaints management, CAPA, continuous improvement, and GMP/GCP/GDP compliance.

What your days could look like Quality Assurance (QA) Oversight

• Qualify andfollow up on external vendors and suppliers by assuring appropriate qualification of those. This includes the management of audits, follow up onCAPA plans, the management of Quality and Technical agreements.
• Oversee key QA processes including deviation and CAPA management, change control, complaints handling, internal and external audits, supplier qualification, document control, and training.
• Establish, maintain, and continuously improve the Pharmaceutical Quality System (PQS) in accordance with EU GMP, ICH, and applicable international standards.
• Review and approve GMP documentation such as BMR/BPR, Master Batch Records, validation protocols and reports.
• Ensure GMPcompliance of facilities, equipment, processes, digital systems, and operations.
• Define and implement the site quality strategy (policies, roadmaps, KPIs) and ensure theQMS is understood, recognized, and applied across the organization.

GMP/ GCP / GDP Compliance

• Build and sustain a strong quality and compliance culture across the site.
• Maintain inspection readiness and lead periodic compliance assessments.
• Oversee validation activities including equipment and utilities qualification, process validation,and analytical validation.
• Conduct supplier and CMO audits and ensure ongoing qualification and performance monitoring.

Qualified Person (QP) Responsibilities and Responsible Person (RP) (GDP and manufacturing of raw materials)

• Act as the sites's primary quality representative to competent authorities and participate in regulatory inspections, overseeing related actions and remediations plans.
• Verify that manufacturing, testing, and documentation fully align with regulatory dossiers (IMPD, CTA, variations,...).
• Ensure QP/RP certification and release of clinical and commercial batches (critical raw materials, DS, DP and finished product) in compliance with EU GMP.

Cross-Functional Collaboration & Technical Leadership

• Partner with internal and external stakeholders to embed quality into, manufacturing, and both pre- and post-market activities.
• Support corporate development of analytical methods and ensure laboratory assets are properly maintained, qualified, and legally compliant.
• Monitor performance metrics, analyse trends, and provide monthly reporting of quality
  
  KPIs.
• Keep leadership informed of regulatory evolutions and advise on associated business impacts.
• Actas key contact during customer audits and supervise the internal audit program.
• Provide strategic input to the site leadership team and contribute to global industrial strategy.

What you bring to the table

• Master’s degree in Pharmacy, Biology,Biotechnology, or equivalent; eligible for EU QP status (certification mandatory).
• 8–12 years of experience in pharmaceutical, biotechnology.
• Proven Qualified Person (QP) experience with clinical and commercial batch release.
• Strong background in GMP-compliant
  
  QA/QC/Compliance oversight.
• Experienced in regulatory inspections(EMA, ANSM, or equivalent).
• Familiar with biologics, ATMPs, phages,vaccines, viral vectors, and filling/packaging processes.
• Skilled in QMS implementation, audits,CAPA, and driving quality culture in growing organizations.
• Expertise in EU GMP, ICH Q8–Q10, QPdirectives, data integrity (ALCOA+).
• Familiarity with GMP/GCP/GDP; lead auditor certification is a plus.
• Strong leadership, organizational, andcross-functional collaboration…