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Recruitment Consultant | Quality Assurance | UK & Europe
We're seeking a QA Manager to drive the build, implementation, and maintenance of a Quality Management System (QMS) from scratch, while supporting operational execution in a fast-paced biotech environment focused on recombinant plasminogen for diabetic foot ulcer treatment.
Key Responsibilities :
Quality Assurance :
* Lead the design and deployment of a robust QMS for early-stage biologics (preclinical to early clinical).
* Ensure compliance with EU / FDA GMP and ICH standards.
* Draft, review, and manage quality documentation (SOPs, WIs, etc.).
* Oversee CMOs and third-party suppliers, ensuring GMP alignment.
* Manage deviations, CAPAs, change control, and batch record reviews.
* Support internal / external audits and document control.
Operations Management :
1. Support CTM readiness and preparation of IMPD / CMC documents.
2. Coordinate project timelines and budgets across departments.
3. Collaborate with R&D, regulatory, and manufacturing teams.
4. Review protocols, Batch Manufacturing Records (BMR), and support tech transfer / scale-up.
Compliance :
5. Maintain regulatory-compliant quality systems.
6. Manage vendor qualification and oversight.
7. Ensure regulatory, IP, and ethical readiness.
Candidate Profile :
8. 3+ years in QA / Operations within biotech or biopharma (start-up / scale-up preferred).
9. Strong knowledge of cGMP and EMA / FDA frameworks.
10. Background in biologics : recombinant proteins, cell / gene therapies.
11. Experience with eCTD Module 3 and CMO / vendor management.
12. Degree in Biotechnology, Pharmacy, Life Sciences, or related field.
13. Fluent in English (additional languages a plus).
Soft Skills
14. Detail-oriented, organized, and efficient under pressure.
15. Excellent communicator and strong with time management.
16. Proficient in Microsoft Office tools.
Why Apply?
17. Join a fast-growing biotech with long-term impact.
18. Clear path to CMC Director role.
19. Long-Term Incentive Plan (L-TIP) included in total compensation.
Apply now or reach out for more information.
Seniority level
Seniority level
Mid-Senior level
Employment type
Employment type
Full-time
Job function
Job function
Quality Assurance
Industries
Biotechnology Research and Pharmaceutical Manufacturing
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