I'm working with a leading global biopharmaceutical organisation who are seeking an experienced QA Senior Specialist to join its expanding Quality team on a 12 month initial contract. This is an exciting opportunity to play a pivotal role within a high‑performing GMP environment dedicated to developing and supplying transformative medicines to patients.
The successful candidate will contribute to a culture of quality excellence, ensuring that manufacturing, testing and distribution activities meet the highest regulatory and compliance standards.
Key Responsibilities
* Act as a QA subject‑matter expert across GMP operations, providing quality oversight to manufacturing, QC laboratories, and supply chain activities.
* Lead and support deviations, CAPAs, change controls, and investigations to ensure timely and compliant closure.
* Perform batch record reviews, product quality assessments, and provide QA approval for release‑related activities (as applicable to the licence framework).
* Support internal and external audits, including preparation, participation, and follow‑up of corrective actions.
* Partner with cross‑functional teams (Manufacturing, MS&T, Engineering, Supply Chain, QC, Validation) to ensure compliance and continuous improvement.
* Contribute to the development and maintenance of GMP documentation, SOPs, and quality systems.
* Provide quality input on technology transfers, equipment qualification, process validation, and change initiatives.
* Drive a strong quality culture, ensuring that compliance expectations are clearly communicated and consistently upheld.
Essential Requirements
* Degree (or equivalent) in a scientific discipline: Life Sciences, Chemistry, Biology, Pharmacy, or related field.
* Significant experience in GMP quality assurance within pharmaceuticals, biologics, or advanced therapies.
* Strong understanding of EU and UK GMP regulations and industry standards.
* Demonstrated expertise in managing deviations, CAPA, change control, and quality systems.
* Excellent communication, stakeholder engagement, and problem‑solving skills.
* Ability to work independently while contributing effectively within a cross-functional team.
Desirable Experience
* Exposure to sterile manufacturing, biologics, cell therapy, or advanced therapy medicinal products (ATMPs).
* Experience supporting regulatory inspections (MHRA, EMA, FDA or equivalent).
* Knowledge of electronic quality systems (e.g. Veeva, TrackWise).
If this is something you'd be interested in, feel free to get in touch - jamie.keith@cpl.com