Quality Assurance Manager

Associate Recruitment Consultant at Apsida Life Science

Job Title: Quality Assurance Manager – Freelancer

Location: Remote-based

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.

Seniority Level

Associate

Employment Type

Contract

Job Function

Accounting/Auditing, Quality Assurance, and Consulting

Industries

Pharmaceutical Manufacturing and Biotechnology Research

Contact

Sweetness.zono@apsida.com
www.apsida.co.uk
+44 744 134 2281

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