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.