Quality Assurance Manager

Company Description: Priothera is leading the way in developing orally delivered sphingosine-1-phosphate (S1P) receptor modulators for hematological malignancies. We are a group of experienced drug development experts coming from big pharma and are developing mocravimod, to enhance the curative potential of allogeneic hematopoietic cell transplantation (HCT).

About the Role

This is a great opportunity for an experienced GCP quality professional to take ownership of key QA activities across a global, pivotal clinical programme. Reporting to the Head of Quality Assurance, you'll provide independent, risk-based quality oversight that supports Priothera's Quality Management System (QMS) and helps ensure our Sponsor responsibilities are met — with trial-participant protection, data integrity and inspection readiness always front and centre.

You'll combine hands-on execution with independent, constructive challenge — working closely with Clinical Operations, Medical, Regulatory, Biometrics and CMC, as well as our CROs and other service providers, while preserving QA's independence.

What You'll Do

• Own assigned QMS processes, controlled documents and their ongoing improvement
• Manage quality events, investigations and CAPAs from intake through to defensible closure
• Support risk-based qualification and oversight of CROs and other service providers
• Provide QA input into clinical-trial risk management, including Critical-to-Quality factors and risk controls
• Plan, conduct and follow up on risk-based audits (internal, service-provider and site level)
• Support continuous inspection readiness, including readiness assessments and inspection response
• Provide QA oversight of GxP computerised systems and data integrity (ALCOA++)
• Deliver pragmatic QA advice and role-based training across the organisation

What You'll Bring

Essential

• A degree in pharmacy, life sciences, medicine, nursing or a related scientific discipline (or equivalent experience)
• 7+ years in clinical research, biotech or pharma, including 4+ years in a GCP quality assurance role
• Hands-on experience managing quality events, investigations, root-cause analysis and CAPAs
• Practical experience with service-provider oversight and GCP audits, including reporting and follow-up
• Strong working knowledge of ICH GCP E6 (R3), the EU Clinical Trials Regulation and FDA GCP expectations
• Fluent written and spoken English

Nice to Have

• Sponsor-side experience on multinational Phase II/III or registration-enabling trials, ideally in oncology or haematology
• Qualified/experienced GCP lead auditor
• Experience overseeing GxP computerised systems, electronic records and audit trails
• Familiarity with GMP/GDP interfaces and pharmacovigilance quality processes
• Experience supporting FDA, MHRA and/or EMA/EU Member State inspections

Why Join Priothera

You'll play a hands-on role in a small, focused biotech advancing a pivotal treatment for patients with limited options — with real autonomy, direct access to senior leadership, and the chance to help shape our quality culture as we grow.

📍 Location: Based in the Saint-Louis Agglomeration area / Remote

📄 Type: Permanent, Full-time

✈️ Travel: Occasional, including audits/inspections

Interested? Apply now to help us bring mocravimod to the patients who need it.