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:
* Support CTM readiness and preparation of IMPD/CMC documents.
* Coordinate project timelines and budgets across departments.
* Collaborate with R&D, regulatory, and manufacturing teams.
* Review protocols, Batch Manufacturing Records (BMR), and support tech transfer/scale-up.
Compliance:
* Maintain regulatory-compliant quality systems.
* Manage vendor qualification and oversight.
* Ensure regulatory, IP, and ethical readiness.
Candidate Profile:
* 3+ years in QA/Operations within biotech or biopharma (start-up/scale-up preferred).
* Strong knowledge of cGMP and EMA/FDA frameworks.
* Background in biologics: recombinant proteins, cell/gene therapies.
* Experience with eCTD Module 3 and CMO/vendor management.
* Degree in Biotechnology, Pharmacy, Life Sciences, or related field.
* Fluent in English (additional languages a plus).
Soft Skills
* Detail-oriented, organized, and efficient under pressure.
* Excellent communicator and strong with time management.
* Proficient in Microsoft Office tools.
Why Apply?
* Join a fast-growing biotech with long-term impact.
* Clear path to CMC Director role.
* Long-Term Incentive Plan (L-TIP) included in total compensation.
Apply now or reach out for more information.