Why this role matters
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 a strategic leader, this role is key in establishing, maintaining, and strengthening a robust quality culture as the company transitions to full GMP operations.
In this position, you will provide oversight of QA, QC, and GMP compliance activities, ensuring that all products meet national and European regulatory requirements. You will also drive 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 and follow up on external vendors and suppliers by assuring appropriate qualification of those. This includes the management of audits, follow up on CAPA 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 GMP compliance of facilities, equipment, processes, digital systems, and operations.
- Define and implement the site quality strategy (policies, roadmaps, KPIs) and ensure the QMS 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.
- Act as 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, QP directives, data integrity (ALCOA+).
- Familiarity with GMP/GCP/GDP; lead auditor certification is a plus.
- Strong leadership, organizational, and cross-functional collaboration skills; experienced in mentoring teams.
- Analytical, autonomous, and proactive, with an entrepreneurial approach to quality and compliance.
- Proficient in MS Office, SharePoint, flowcharting software, Acrobat.
- Excellent written and verbal communication skills in English and French.
- Ability to operate in fast-growing, high-demand, evolving environments, structuring processes and teams for sustainable compliance
What you’ll love about working here
Inspiring Mission
oin a high-potential biotech fighting antimicrobial resistance with cutting-edge science.
Impactful Work
Contribute to solutions that make a real difference in patients' lives.
Growth Opportunities
Develop your skills and grow professionally in a dynamic environment.
Innovation Culture
Be part of a team that values collaboration, creativity, and mission-first thinking.
Attractive Compensation
Enjoy a competitive package aligned with your role and experience.
Work-Life Flexibility
Benefit from hybrid work and flexible hours tailored to your lifestyle.
Supportive Team
Join a passionate team that supports each other every step of the way.
Fun & Team Spirit
Enjoy team breakfasts, lunches, afterworks, and memorable team-building moments.
Ready to make an impact?
We’d love to hear your story. Apply today!