Apsida Life Science are currently partnered with an innovative and fast-growing Biopharmaceutical company who are looking to appoint a Quality Operations Manager / Senior Manager to support their expanding global Quality function.
This individual will play a critical role in ensuring product quality and GMP compliance across commercial and clinical drug substance and drug product operations, with a strong focus on EU market distribution oversight, CMO/CTL management, and Quality Operations leadership.
This individual will report directly into senior Quality leadership and work cross-functionally across CMC, Supply Chain, Regulatory, and external manufacturing partners.
Responsibilities:
- Act as the Quality lead supporting a variety of Chemistry, Manufacturing and Controls (CMC) projects.
- Provide Quality oversight and support investigations related to contract manufacturing and testing organizations (CMOs/CTLs).
- Perform review of executed batch records, test data, and support product disposition activities.
- Review and approve validation protocols and reports including process and analytical method validations.
- Lead and support supplier, CTL, and CMO quality audits.
- Generate, review, and maintain Quality and Technical Agreements with Contract Service Providers (CSPs).
- Author and revise SOPs and controlled documentation in accordance with global GMP requirements.
- Oversee 3PL activities and liaise with Qualified Persons (QPs) and cross-functional teams to ensure compliant EU product distribution.
- Ensure QP/RP release activities are completed where required.
Experience required:
- Bachelor’s or Master’s degree in Science, Engineering, or related discipline.
- At least 7 years’ experience within the Bio/Pharmaceutical industry.
- 5–10 years of Quality Assurance experience within GMP-regulated environments.
- Strong knowledge of 21 CFR Part 211, global cGMP regulations, and ICH guidelines.
- Extensive experience working within EU Quality Management Systems and EU country-specific requirements.
- Strong understanding of pharmaceutical manufacturing processes and analytical chemistry.
- Hands-on experience reviewing executed batch records and supporting product release activities.
- Experience supporting supplier, CTL, and CMO audits.
- Ability to work independently within cross-functional project teams in a fast-paced environment.
- Willingness to travel as required
Apsida Life Science is a specialist recruitment business based in London (UK), Redhill (UK) & Boston (USA) 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.