GCP Quality Assurance (QA) Manager

Do you pride yourself on your integrity? We do what’s right for employees, patients and partners, and so can you.

Oxford Biomedica’s Quality Assurance team is responsible for the companies quality processes and systems, in compliance with GMP, GLP and GCP guidelines. The team are accountable for internal and external audits, quality compliance and control.

We are currently recruiting for a GCP Manager join us and be responsible for GCP QA activities whilst also ensuring GLP activities are supported. The primary aim of the role is to ensure quality and compliance of Oxford Biomedica (UK) Ltd. sponsored clinical trials with respect to Standard Operating Procedures, applicable regulatory requirements (FDA, EU, ICH & country specific, and current industry standard’s and practices) and support Translational Sciences with ensuring GLP studies are conducted in a compliant manner.

Your responsibilities in this role would be:

• Participate in the development, implementation, and maintenance of the company’s GCP & GLP quality management system and facilitate continuous improvement.
• Work closely with the QA Manager overseeing GLP activities.
• Provide GCP and GLP QA oversight and support to internal staff and represent QA on GCP & GLP related project teams.
• Assist in the development/maintenance of GLP and GCP related SOPs and other quality documents.
• Develop and implement annual audit strategies, and quarterly GCP audit schedules (and GLP schedules if required).
• Schedule, oversee and perform (either directly or via external auditors) routine and non-routine quality assurance audits to include, but not limited to: clinical investigator sites, animal testing sites, vendors, process, and systems.
• Assist in the selection of external auditors, coordinate audits, and associated documentation in a timely manner.
• Support internal and external GLP testing to ensure compliance with guidelines, SOPs, protocols, and industry standards.
• Conduct QA review of GLP methods, data and reports.
• Assure/coordinate proper and complete resolution of findings/non-compliant situations in a timely manner, including approval of corrective action/preventive action (CAPA) plans, as necessary.
• Conduct QA review of GCP protocols, ICFs, CSRs and other clinical trial specific documents.
• Participate in the preparation and conduct of inspections and audits performed by regulatory authorities and other parties.

To be successful in this role, you will have the following skills and experience:

• Bachelor’s Degree in a scientific discipline
• A strong working knowledge of GCP, GLP and ICH requirements
• Previous experience within Advance Therapeutic Medicinal Products (ATMPs)
• Proven experience in the Pharmaceutical industry within QA
• Strong verbal and written communication skills
• Excellent organization and multi-tasking skills
• Ability to think strategically in order to improve current processes
• Ability to work independently and prioritise with minimal supervision
• Ability to work effectively across a matrix organisation

Do you want to feel inspired every day? We’re future-focused and our business is growing rapidly. We succeed together through passion, commitment and team work, and so can you.

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