Quality Assurance Manager

3 weeks ago

england, United Kingdom Apsida Life Science Full time

Job Title: QA Manager (Consultant) – GCP Compliance (Biotech / Phase II) About the Company We are a growing biotechnology company advancing Phase II clinical programs . As we expand our clinical operations and global trial footprint, we are strengthening our Quality Management System and GCP oversight. We are seeking an experienced QA Manager (Consultant) who brings strong GCP quality expertise and hands-on experience supporting teams through MHRA and FDA regulatory expectations. This is a contract / part-time / fractional role with flexible engagement structure. Role Overview The QA Manager (Consultant) will lead GCP quality assurance activities across ongoing clinical trials, vendors, and documentation systems. The ideal candidate brings practical, scalable approaches to quality in a mid-stage biotech environment , and can both advise strategically and execute hands-on quality tasks . Key Responsibilities Oversee and maintain GCP components of the Quality Management System (QMS) to support Phase II clinical activities. Perform clinical site audits , vendor/CRO audits , and internal process audits. Ensure ongoing GCP compliance throughout clinical trial execution. Serve as QA representative for inspection readiness and regulatory interactions, including MHRA and FDA expectations. Review and approve clinical documentation , including protocols, Investigator Brochures, monitoring plans, TMF records, deviations, and CAPAs. Support development and maintenance of SOPs and training programs for clinical and cross-functional teams. Provide coaching and guidance to Clinical Operations, Medical, and outsourced partners. Support preparation, response, and CAPA follow-up for inspections and audits . Qualifications Required 7+ years of Quality Assurance experience in biotechnology, pharma, or CRO environment. Strong GCP quality background supporting Phase I–III clinical trials . Demonstrated experience preparing for and supporting MHRA and FDA inspections. Experience conducting clinical site audits and vendor audits . Ability to evaluate and improve QMS processes in a growing organization. Excellent communication, collaboration, and documentation skills. Preferred Experience with EU trials or global Quality oversight. Familiarity with TMF structure and metrics . Engagement Details Consulting / Contract / Fractional role Estimated workload: 0.4 - 0.5 FTE , depending on stage and needs Remote or hybrid, with occasional on-site meetings or audits as required Contract duration: 12 months with potential extension

  • Quality Assurance Manager

    5 days ago

    Gatwick, England, United Kingdom Morgan Sindall Infrastructure Full time

    Gatwick with Site Visits when required.Talented people are the key to our success.Would you like to work for an inclusive and collaborative company which is also one of the most successful within the UK infrastructure industry?We are looking for a motivated and ambitious Quality Assurance Manager to join our team working on our Gatwick Pier 3 Project and...

  • Quality Assurance Manager

    16 hours ago

    Surrey, England, United Kingdom Alexander Steele Recruitment Full time £100,000 - £150,000 per year

    Quality Assurance ManagerI am partnering exclusively with a well-established chilled food manufacturer to support them with the recruitment of an experienced Quality Assurance Manager who will play a key role in strengthening the site's technical and quality agenda. This is an excellent opportunity for a confident QA professional who enjoys autonomy,...

  • Quality Assurance

    2 weeks ago

    Kent, England, United Kingdom b3 jobs ltd Full time £55,000 per year

    Quality Assurance & Regulatory ManagerThis is a well-established, forward-thinking food manufacturer with a strong reputation for innovation and sustainability. The business is committed to producing high-quality products using ethical practices, certified supply chains, and renewable energy.About the Quality Assurance & Regulatory Manager jobThe purpose of...

  • Quality Assurance Officer

    1 day ago

    Hertfordshire, England, United Kingdom Hyper Recruitment Solutions Full time £30,000 - £50,000 per year

    ROLE OVERVIEWWe are supporting a leading pharmaceutical company based in the Hertfordshire area who are seeking a dedicated Quality Assurance Officer. This role offers a chance to be at the forefront of ensuring quality standards and regulatory compliance within a dynamic environment. As the Quality Assurance Officer, you will play a crucial role in...

  • Quality Assurance

    2 weeks ago

    Manchester, England, United Kingdom Campus Living Villages Full time £40,000 - £70,000 per year

    Who we areCampus Living Villages are a leading, global student accommodation provider, we are home to over 11,000 students in the UK and 27,100 worldwide.We are passionate about creating a great place to work for our employees, whilst providing an environment where our residents can Live, Learn and Grow. We're proud to have over 20 years' experience funding,...

  • Quality Assurance Manager and Qp

    6 days ago

    South East England, United Kingdom WALKER COLE INTERNATIONAL LTD Full time

    Walker Cole International are searching for a Quality Assurance Manager and Qualified Person to join a well-established international pharmaceutical business in the South-East. As a QA Manager and QP you will be a key part of managing the business' qualityfunctions and performing routine batch release activities. You will be responsible for: - Developing,...

  • Quality Assurance Manager

    2 weeks ago

    Lancashire, England, United Kingdom Seven Search and Selection Ltd Full time £45,000 - £65,000 per year

    Quality ManagerPremium Food BrandLancashireAbout Our Client:A market-leading UK food manufacturer with a proud heritage and instantly recognisable brands enjoyed by millions of consumers every week.A business driven by quality, innovation, and continuous improvement, investing heavily in people, processes, and sustainable growth.A fast-paced, values-led...

  • Quality Assurance Officer

    2 weeks ago

    South West England, United Kingdom WALKER COLE INTERNATIONAL LTD Full time

    Walker Cole International is searching for a Quality Assurance Officer to join a growing Biopharmaceutical company based in South West England. As a Quality Assurance Officer you will be contributing to the development of the quality system and providing support for manufacturing operations. **Responsibilities**: - Covering all Quality Systems relating to...

  • Quality Assurance Lead

    2 weeks ago

    Hampshire, England, United Kingdom GTS Group Ltd Full time £45,000 - £65,000 per year

    Are you passionate about delivering exceptional quality standards and ensuring every product meets exacting expectations? We're looking for a Quality Assurance Lead to take ownership of quality processes at our clients' advanced manufacturing site in Hampshire.In this role, you'll be the driving force behind inspection, compliance, and continuous improvement...

  • Quality Assurance Manager

    3 days ago

    Stansted Mountfitchet, England, United Kingdom JMC Aviation Full time

    Job Title: Safety and Quality Monitoring ManagerLocation: StanstedEmployment Type: PermanentStart Date: ASAPShifts: Monday- Friday 39 hours per weekBenefits:25 days annual leave + bank holidaysSalary Exchange Pension SchemeEmployee Assistance ProgrammeLife AssuranceEmployee Cash PlanEnhanced Maternity and Paternity SchemesProfessional Growth and...