Quality Assurance Consultant
Posted 1 day ago by Apsida Life Science
Negotiable
Undetermined
Remote
United Kingdom
Summary: The Quality Assurance Consultant (GCP) role at Apsida Life Science involves providing QA oversight for Phase 2 clinical trials within a clinical-stage biopharmaceutical company. The position requires ensuring compliance with GCP requirements and managing audits and regulatory interactions. The role is remote and spans a duration of 12 months, focusing on quality systems and risk management in clinical development. Candidates should have significant experience in the biotech industry and relevant qualifications in life sciences.
Key Responsibilities:
- Provide QA oversight for Phase 2 clinical trials, ensuring full compliance with GCP requirements and applicable SOPs.
- Conduct and support GCP audits (internal, vendor, and investigator site audits) and manage CAPAs to closure.
- Ensure clinical activities comply with FDA and MHRA regulatory expectations, supporting inspections and regulatory interactions.
- Advise biotech project teams on quality systems, risk management, and compliance throughout the clinical development lifecycle.
- Review and approve clinical trial documentation to ensure accuracy, consistency, and regulatory readiness.
Key Skills:
- GCP experience
- Relevant Life Science degree
- Minimum of 5 years experience
- Own Limited Company (preferred)
- Biotech industry experience
- FDA/MHRA regulatory experience
- Phase 2 clinical trial experience
- Auditing
Salary (Rate): undetermined
City: undetermined
Country: United Kingdom
Working Arrangements: remote
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
Apsida Life Science have partnered with a leading biotech and research company to present the following role:
Company Overview
This clinical-stage biopharmaceutical company develops precision small-molecule therapies targeting key immune signaling pathways for neurological and immune-mediated diseases. Its pipeline includes oral and topical candidates for neuroinflammatory and dermatologic conditions, with lead programs in early clinical development and supported by strong venture backing.
Job Title- Quality Assurance Consultant (GCP)
• Location: UK
• Type- Remote
• Duration- 12 months
Key Responsibilities
- Provide QA oversight for Phase 2 clinical trials, ensuring full compliance with GCP requirements and applicable SOPs.
- Conduct and support GCP audits (internal, vendor, and investigator site audits) and manage CAPAs to closure.
- Ensure clinical activities comply with FDA and MHRA regulatory expectations, supporting inspections and regulatory interactions.
- Advise biotech project teams on quality systems, risk management, and compliance throughout the clinical development lifecycle.
- Review and approve clinical trial documentation to ensure accuracy, consistency, and regulatory readiness.
Requirements
- GCP experience
- Relevant Life Science degree
- Minimum of 5 years experience
- Own Limited Company (preferred)
- Biotech industry experience
- FDA/MHRA regulatory experience
- Phase 2 clinical trial experience
- Auditing
If you are interested in learning more, please reach out to Mufaro Mpofu: mufaro.mpofu@apsida.com
Apsida Life Science is a specialist recruitment business based in London (UK), Redhill (UK), Boston (USA) & Pretoria (South Africa) that is dedicated to delivering the best talent to the Life Science industry. We believe there is a gap in the market for a cost effective, high quality and trusted recruitment service that puts the candidate journey at the heart of the recruitment process.