A global, biopharmaceutical company is seeking a Quality Director to join their team in Oxfordshire, UK.
The Quality Director UK role will represent Global Quality Assurance supporting the company clinical pipeline with a primary focus on European contract manufacturing and company UK based development activities. This position will be the lead Quality representative for the UK responsible for interfacing with the US based Global Quality Organization to provide Quality Assurance oversight for current Good Manufacturing Practice (cGMP) and Good Laboratory Practice (GLP). The scope of the position includes establishment of an integrated quality system inclusive of validation, change control, CAPA, documentation management, and compliance.
- As the primary point of contact for Quality in the UK, provide senior level cGMP expertise and oversight for regulatory compliance.
- In collaboration with the US based Global Quality Organization, act as the primary point of contact in the UK for the Electronic Quality Management System management. Functional owner in the UK for quality systems including lot release, documentation process flows, quality risk management, data integrity systems, and internal and external auditing processes. Provide final Quality approval of all documentation (SOPs, Protocols, Reports, etc.) supporting GMP or GLP operations as required.
- Oversee and monitor Quality standards as required with particular focus on development and technology transfer. Responsible for establishment of procedural framework for identifying, collecting, distributing and filing controlled documents supporting manufacturing, development, technology transfer, and GLP laboratories in the UK.
- Responsible for lot release for products manufactured and distributed in the European Union. Ensure that all products released from company UK meet US (FDA) and European (EMA) standards of strength, identity, safety, purity, and quality (SISPQ).
- Own and lead the company-UK Quality planning process in order to drive continuous improvement.
- Responsible for defining the appropriate level of training required for several Quality Management System processes in the UK and collaboration with the training manager to ensure requirements are implemented.
- Responsible for managing all regulatory inspection activities in the UK in support of ongoing clinical trials as required.
Qualifications & Experience:
- Degree in science or engineering, advanced degree preferred.
- Must have significant experience in managing a quality function including direct experience supporting development and technology transfer activities.
- Proven track record managing quality functions for a small, growing company.
- Superior knowledge of regulatory compliance for autologous therapies, lot release, and quality systems.
- Must possess "Subject Matter Expertise", including knowledge and demonstrated application in one or more of the following areas; t-cell therapies, virus manufacture, Biologics, Vaccines, or Sterile Drug Product manufacture.
- Establishing data integrity systems
- Developing and performing GMP training
- Possess a thorough knowledge of computer applications in the Microsoft Office Suite; including scanning of documentation.
- Registered Qualified Person (QP) per Directive 2001/83/EC for Medicinal products for human use.
- Proven track record supporting complex process validation strategies for biologics, vaccines, or autologous sterile products.
- Candidate must have excellent organization, documentation, and communication skills.
- Candidate must be proficient in Microsoft Word, Excel, Power Point, and MS Project.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Courtney Russell on +44 203 8141 315 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.