Phage
As QA Manager & Qualified Person (QP) , you will be responsible for the release of Raw Material for MagistralPreparation, clinical and commercial batches and overseen the entirepharmaceutical Quality Management System (QMS) at the site. Acting as astrategic leader, this role is key in establishing, maintaining, andstrengthening 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, continuousimprovement, and GMP/GCP/GDP compliance.
What your days could look like QualityAssurance (QA) Oversight
Qualify andfollow up on external vendors and suppliers by assuring appropriatequalification 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 andapprove GMP documentation such as BMR/BPR, Master Batch Records, validationprotocols and reports.
Ensure GMPcompliance of facilities, equipment, processes, digital systems, andoperations.
Define andimplement 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 validationactivities including equipment and utilities qualification, process validation,and analytical validation.
Conduct supplierand 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-FunctionalCollaboration & 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.
Monitorperformance metrics, analyse trends, and provide monthly reporting of qualityKPIs.
Keepleadership informed of regulatory evolutions and advise on associated businessimpacts.
Actas key contact during customer audits and supervise the internal audit program.
Providestrategic input to the site leadership team and contribute to global industrialstrategy.
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 inpharmaceutical, biotechnology.
Proven Qualified Person (QP) experiencewith clinical and commercial batch release.
Strong background in GMP-compliantQA/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; leadauditor certification is a plus.
Strong leadership, organizational, andcross-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 verbalcommunication skills in English and French.
Ability to operate in fast-growing,high-demand, evolving environments, structuring processes and teams forsustainable compliance
What you’ll love about working here
Join a high-potential biotech fighting antimicrobial resistance with cutting-edge science.
Contribute to solutions that make a real difference in patients' lives.
Develop your skills and grow professionally in a dynamic environment.
Be part of a team that values collaboration, creativity, and mission-first thinking.
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.
Develop your skills and grow professionally in a dynamic environment.
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.
Enjoy team breakfasts, lunches, afterworks, and memorable team-building moments.
Ready to make an impact? We’d love to hear your story. Apply today!
#J-18808-Ljbffr
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, continuousimprovement, and GMP/GCP/GDP compliance.
What your days could look like QualityAssurance (QA) Oversight
Qualify andfollow up on external vendors and suppliers by assuring appropriatequalification 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 andapprove GMP documentation such as BMR/BPR, Master Batch Records, validationprotocols and reports.
Ensure GMPcompliance of facilities, equipment, processes, digital systems, andoperations.
Define andimplement 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 validationactivities including equipment and utilities qualification, process validation,and analytical validation.
Conduct supplierand 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-FunctionalCollaboration & 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.
Monitorperformance metrics, analyse trends, and provide monthly reporting of qualityKPIs.
Keepleadership informed of regulatory evolutions and advise on associated businessimpacts.
Actas key contact during customer audits and supervise the internal audit program.
Providestrategic input to the site leadership team and contribute to global industrialstrategy.
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 inpharmaceutical, biotechnology.
Proven Qualified Person (QP) experiencewith clinical and commercial batch release.
Strong background in GMP-compliantQA/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; leadauditor certification is a plus.
Strong leadership, organizational, andcross-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 verbalcommunication skills in English and French.
Ability to operate in fast-growing,high-demand, evolving environments, structuring processes and teams forsustainable compliance
What you’ll love about working here
Join a high-potential biotech fighting antimicrobial resistance with cutting-edge science.
Contribute to solutions that make a real difference in patients' lives.
Develop your skills and grow professionally in a dynamic environment.
Be part of a team that values collaboration, creativity, and mission-first thinking.
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.
Develop your skills and grow professionally in a dynamic environment.
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.
Enjoy team breakfasts, lunches, afterworks, and memorable team-building moments.
Ready to make an impact? We’d love to hear your story. Apply today!
#J-18808-Ljbffr