About this job:
The QA Manager will be responsible for overseeing quality systems and supporting day-to-day operational execution within a fast-paced biotech environment. This role ensures that processes supporting the development and manufacturing of recombinant plasminogen for diabetic foot ulcer treatment meet all relevant GMP, regulatory, and internal standards.
Key Responsibilities:
Quality Assurance:
* Ensure compliance with EU/FDA GMP regulations and relevant ICH documentation standards.
* Draft, review, and maintain SOPs, work instructions, and other quality documents.
* Manage internal audits and assist in the coordination of external GMP and vendor audits.
* Provide QA oversight for CMOs and third-party providers.
* Contribute to batch record reviews, manage deviations, CAPA, change control, and oversee document control activities.
* Develop and sustain a robust Quality Management System (QMS) for early-stage biologics (from preclinical to early clinical phases).
Operations Management:
* Support clinical trial material (CTM) production readiness and preparation of IMPD and other CMC documentation.
* Monitor project timelines, coordinate resource planning, and align with operational budgets.
* Work cross-functionally with R&D, regulatory, and manufacturing teams to maintain operational documentation.
* Review and evaluate manufacturing protocols and Batch Manufacturing Records (BMR).
* Assist with tech transfer and scale-up processes alongside external manufacturing partners.
Compliance Responsibilities:
* Implement and maintain quality systems in accordance with regulatory expectations.
* Ensure ongoing GMP compliance across all quality and operational processes.
* Oversee vendor qualification and ongoing management.
* Enable IP and regulatory readiness, and support legal and ethical standards.
Candidate Profile:
* 3+ years of experience in Quality Assurance and/or Operations within biotech or biopharma, preferably in a start-up or scale-up environment.
* In-depth understanding of cGMP practices and EMA/FDA regulatory frameworks and documentation expectations.
* Background in working with biologics, such as recombinant proteins, cell therapy, or gene therapy.
* Experience with eCTD Module 3 documentation requirements.
* Proven ability to manage third-party vendors and CMOs and implement QMS in a fast-moving setting.
* Bachelor’s or Master’s in Biotechnology, Pharmacy, Life Sciences, or a closely related field.
* Fluent in spoken and written English; other languages are beneficial.
Soft Skills:
* Highly detail-oriented and organized.
* Strong communicator with excellent time management and ability to prioritize effectively.
* Comfortable using Microsoft Office for documentation and reporting.
Why Apply:
* Join a fast-growing, early-stage biotech
* Clear progression path with potential to grow into a CMC Director role
* Long-Term Incentive Plan (L-TIP) included as part of total compensation
If you're looking to advance your career in a fast-paced, early-stage pharmaceutical environment,
apply now or reach out for more details:
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☎ +44 (0) 1293 776644