GMP Operational Quality Manager (Biotech)

TL;DR

GMP Operational Quality Manager (Biotech): Managing and overseeing the QA batch disposition process for Cell & Genetic Therapeutic programs with an accent on compliance, batch record review, and stakeholder collaboration. Focus on driving quality execution, managing deviations and CAPAs, and ensuring adherence to global GMP regulations (FDA, EU, ICH).

Location: Hybrid (up to 2 days remote) or On-Site in Paddington, United Kingdom

Company

Vertex is a global biotechnology company that invests in scientific innovation.

What you will do

• Lead QA execution for the review, disposition, and archiving of Cell & Genetic (C&G) Therapy batches manufactured externally.
• Review and approve batch records, deviations, in-process data, EM data, and QC release testing.
• Manage QA disposition change controls, OOS investigations, and associated CAPAs.
• Approve Certificates of Analysis (COAs) and product labelling.
• Identify compliance risks and gaps in GMP disposition processes and implement mitigating controls.
• Support technical transfer and Process Performance qualification batch review and disposition.

Requirements

• Master's or Bachelor's degree in a biotech or Lifesciences field.
• Extensive industry experience in operational quality assurance or quality control within a regulated pharmaceutical/biotech environment.
• Proven expertise in Batch Release, Root Cause Analysis, and CAPA management.
• Deep knowledge of cGMP regulations (EU, FDA, ICH, USP) and Cell/Gene therapy processing.
• Proficiency with network-based applications such as Oracle, TrackWise, and Veeva.
• Ability to travel up to 15%.

Culture & Benefits

• Flexible work arrangement: choice between Hybrid (up to 2 days remote) or On-Site.
• Commitment to equal employment opportunity and non-discrimination.
• Working within a global biotechnology company focused on scientific innovation.