Senior QA Specialist
About the Role
We are seeking an experienced Senior QA Specialist to join a growing biotech organization focused on the development of live bacterial micro-organisms for use as vaccines and live bio therapeutical products (LBPs). This role is a key quality subject matter expert position, driving quality strategies and ensuring compliance across in-house operations and outsourced manufacturing partners.
The company provides GMP-compatible process and analytical development, process characterization, and QC services to support the development of live biologicals. With an established Quality Management System (QMS) and cGMP license for QC testing of Investigational Medicinal Products (IMPs), the organization supports clients through pre-clinical and clinical phases I–III, and is actively working towards commercial manufacturing readiness.
Key Responsibilities
Partner with QA, QC, and Development leadership, as well as outsourced CMC manufacturing partners.
Continuously improve and strengthen the Quality Management System (QMS).
Provide leadership in QA knowledge-sharing and training across the organization.
Define and implement PAI readiness strategies for both the internal QC laboratory and contracted CDMOs.
Contribute to management reviews and internal audit programs.
Drive implementation and validation of an electronic QMS (eQMS).
Ensure compliance with data integrity and computerized system validation requirements.
Perform and support quality and process risk assessments.
Audit CDMO facilities to confirm cGMP compliance, PPQ readiness, and inspection preparedness.
Qualify and maintain CDMOs for Drug Substance, Drug Product, and Cell Bank production.
Provide quality oversight of CDMO manufacturing activities and quality systems.
Review and approve technology transfer documentation, Master Batch Records, and specifications.
Serve as quality reviewer/approver for deviations, change controls, CAPA, and OOX investigations.
Review executed batch records, risk assessments, and root cause investigations.
Identify compliance risks or gaps and implement mitigation strategies.
Qualifications & Competences
Master's degree in pharmaceutical sciences, bioengineering, biomedical sciences, or a related field (or equivalent experience).
10–15 years of QA experience in GMP environments, with a focus on late-stage clinical and commercial manufacturing.
At least 5 years overseeing outsourced manufacturing, ideally in biologicals.
Strong knowledge of cGMP (EudraLex Vol 4), EP/USP, ICH/WHO guidelines, and 21 CFR.
Hands-on experience with Process Performance Qualification (PPQ) and QA support for Biologics License Applications (BLA).
Track record of involvement in health authority inspections, including FDA.
Excellent organizational, communication, and leadership skills.
Fluent in English; other languages are an advantage.
Ability to work independently, lead and mentor QA staff, and thrive in a fast-paced, dynamic environment.
Detail-oriented, pragmatic, and solutions-driven.