Job Title: Quality Assurance Manager - Freelancer
Location: Remote-based
Workload: 0.4 – 0.6 FTE
Company Overview:
Apsida Life Science is currently partnering with a fast-growing, innovation-driven biotechnology company developing next-generation therapies in immunology and inflammation. The organisation is advancing multiple clinical programmes, including Phase 1 and Phase 2 studies, and operates in a collaborative, science-focused environment with a strong emphasis on quality and regulatory excellence.
Responsibilities:
* Serve as the QA lead for GCP-related activities across clinical programmes.
* Provide expert guidance to ensure compliance with global GCP requirements and internal quality standards.
* Support or lead interactions with MHRA and FDA, including preparation for regulatory meetings and inspections.
* Provide QA oversight for Phase 2 clinical studies, ensuring readiness for future development stages.
* Lead investigation meetings, manage deviations, and drive effective CAPAs.
* Plan, conduct, and follow up on internal and external audits (vendors, sites, and study processes).
* Partner with Clinical Operations, Regulatory, and external stakeholders to ensure consistent quality governance.
* Contribute to continuous improvement of QA processes, SOPs, and clinical quality systems.
Qualifications:
* Strong experience in GCP Quality Assurance; GMP exposure is a plus but secondary to GCP expertise.
* Background in biotech or pharmaceutical organisations (biotech highly preferred).
* Hands-on experience with MHRA/FDA regulatory expectations and inspection processes.
* Experience supporting or overseeing Phase 2 clinical trials.
* Demonstrated ability to lead investigation meetings and manage quality issues.
* Proven experience conducting or supporting audits within a clinical QA environment.
If you are interested in learning more, please reach out to Sweetness Zono at Apsida Life Science:
Sweetness.zono@apsida.com
www.apsida.co.uk
+44 744 134 2281
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 quality and trusted recruitment service that puts the candidate journey at the heart of the recruitment process