Quality Assurance Consultant

4 weeks ago

london, United Kingdom Hlx Life Sciences Full time

Hlx Life Sciences are partnered with an innovative US-based Biotech, who are seeking an experienced QA Consultant to provide strategic and operational oversight for clinical trials and regulatory compliance. The role will work closely with Clinical Operations, Clinical Development, and Pharmacovigilance teams, while providing QA oversight for outsourced partners. The successful candidate will help ensure clinical programmes are conducted to the highest quality standards, supporting both global trial execution and regulatory readiness. Key Responsibilities Lead GCP QA oversight for global clinical trials, with a focus on UK and EU sites, ensuring compliance with MHRA, EMA, FDA, and ICH guidelines. Review, draft, and approve clinical trial documentation, including protocol amendments, ICFs, TORO, CSRs, DSURs, and regulatory submissions. Plan, conduct, and oversee vendor and site audits (CROs, CTLs, UK/EU investigator sites), including audit preparation, report review, CAPA management, and inspection readiness. Provide TMF QA oversight, ensuring documentation quality, eTMF compliance, and inspection readiness. Implement and maintain GxP-compliant SOPs, policies, and training, including controlled changes, GMP inductions, and GCP/ICH E6 R2/R3 updates. Manage quality issues, root cause analyses, and CAPAs, providing guidance on deviations, risk assessments, and corrective actions. Support GMP-related QA activities for clinical supplies, process validation, and outsourced manufacturing of ATMPs and biologics as they relate to clinical trials. Lead quality culture initiatives, delivering training programs for internal staff and external partners, mentoring junior QA staff, and promoting continuous improvement. Experience & Qualifications BSc (Hons) in Biomedical Science, Pharmaceutical Science, or related field (advanced degree preferred). 10+ years of QA experience in biotech, biologics, or pharmaceutical clinical operations, with strong GCP and GMP expertise. Proven experience leading UK/EU-based audits and inspections, including MHRA and FDA, with remote auditing capability. Hands-on experience with electronic QMS and TMF systems (e.g., TrackWise, MasterControl, Veeva, LIMS, Pro Evo). Strong SOP writing, implementation, and controlled document management experience. Proven ability to provide QA oversight in outsourced or virtual models (CROs, CTLs, UK/EU sites). Experience in inspection readiness, mock inspections, and gap analysis. Excellent communication, stakeholder management, and mentoring skills. Ability to manage multiple priorities in a fast-paced, global environment.

  • Junior Quality Assurance

    2 weeks ago

    London Area, United Kingdom State of Flux Full time £40,000 - £70,000 per year

    Company DescriptionState of Flux is a global procurement and supply chain consultancy based in London, UK, with offices across Europe, the United States, and Asia Pacific. The company specializes in supplier management, contract life-cycle management, category management, and strategic sourcing. In addition to consulting services, State of Flux offers...

  • Quality Assurance Specialist

    4 days ago

    London, United Kingdom Alimentiv Full time

    **POSITION LOCATION**: Canada, US, Germany, UK, Netherlands (Office or Home-based) **POSITION TITLE**: Quality Assurance Specialist **POSITION REPORTS TO**: Director, Quality Assurance **DEPARTMENT/UNIT NAME**:Quality Assurance **JOB SUMMARY**: Alimentiv is looking for an IT focused Quality Assurance Specialist responsible for providing senior support in...

  • Enfield -quality Assurance Consultant Within Youth

    2 weeks ago

    London, United Kingdom Eden Brown Synergy Full time

    We are looking for a high calibre experienced and motivated Quality Assurance Consultant within Youth Offending Service in Enfield Council. Payrate : £43 P/h Postholder will be responsible for: - Providing operational lead on implementing YOS quality assurance programme of work, driving service improvement whilst ensuring quality standards are...

  • Quality Assurance Manager

    5 days ago

    London, United Kingdom Aggregator Network Full time

    Quality Assurance Manager - Durham County Council.This is a full time temporary role (37 hours per week) lasting for a minimum of 5 months. The office base for this role is Abbeywoods Business Park in Durham DH1.About the role/team:Durham County Councilare currently looking to recruit a Quality Assurance Manager to work alongside their existing Quality...

  • Practice and Quality Assurance Consultant

    2 days ago

    London, United Kingdom Business Smart Solutions Full time

    Following the redesign of our service, we have invested in creating a new dedicated practice and quality assurance post to lead effective practice within delivery of youth justice services. The post holder will lead on our quality assurance programme of work, workforce development and commissioned health provision, supporting the Head of Service and...

  • Quality Assurance Manager

    9 hours ago

    London, Greater London, United Kingdom Apsida Life Science Full time

    Job Title:QA Manager (Consultant) – GCP Compliance (Biotech / Phase II)About the CompanyWe are a growing biotechnology company advancingPhase 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 experiencedQA Manager (Consultant)who...

  • Quality Assurance Manager

    1 week ago

    London, United Kingdom Alexander Steele Recruitment Full time

    Alexander Steele Recruitment provided pay rangeThis range is provided by Alexander Steele Recruitment. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.Base pay rangeDirect message the job poster from Alexander Steele RecruitmentSenior Consultant | Food Safety, Quality & NPD Specialist within the Food,...

  • Quality Assurance Manager

    2 weeks ago

    London, United Kingdom Methods Business and Digital Technology Full time

    DescriptionMethods is a 100M IT Services Consultancy who has partnered with a range of central government departments and agencies to transform the way the public sector operates in the UK. Established over 30 years ago and UK-based we apply our skills in transformation delivery and collaboration from across the Methods Group to create end-to-end business...

  • Assurance Consultant

    2 weeks ago

    London, United Kingdom Pay.UK Full time

    Assurance Consultant, Hybrid, London15 month Fixed Term ContractSummaryWe have an exciting opportunity for an experienced individual with a background in financial services to join our Assurance Team as an Assurance Consultant. In this role, you will use your knowledge of payments and risk to undertake complex assurance work, support a team of assurance...

  • Quality Assurance

    1 week ago

    London, Greater London, United Kingdom Fusion Consulting Full time £80,000 - £120,000 per year

    Company DescriptionTransforming Life Science Consulting Worldwide.Fusion Consulting is a globally leading Business and IT boutique consultancy specialized in the Life Sciences industry, partnering with leading companies in pharma, healthcare, and animal health.With over 450 employees and 25 offices worldwide, our mission is to revolutionize our clients'...