Quality Assurance Director

• Full-time permanent position
• Hybrid working – 2/3 days WFH, 2/3 days office (Gloucester)
• Competitive package
• Global pharma company

The Role

As an experienced Quality Assurance Director, you will:

• Have an extensive and detailed knowledge of Good Manufacturing Practice (GMP), ideally gained in a generic injectable medicines environment.
• Have a clear and demonstrable understanding of the CMC aspects of regulatory affairs and their importance to product development and lifecycle maintenance.
• Leverage this technical & regulatory knowledge, to mitigate risks.
• Ensure that the requirements of the Marketing Authorisation relating to the safety, quality and efficacy of the products, are systematically incorporated into all the manufacturing, control and release for sale arrangements of all finished products.
• Have proven experience of implementing/managing quality systems in a GxP environment, including Continuous Quality Improvement.
• Drive effective management of quality investigations and CAPAs and make decisions that may involve complex quality and technical issues.
• Ensure that: deviation reports are investigated; the information is documented with sound scientific justification; adequate impact assessments are provided; appropriate root cause identified and meaningful correct/preventive actions are proposed and implemented.
• Support the EU QPPV and German counterparts by taking an active role in managing product recalls and reporting quality defects and OOS results/ deviations to relevant authorities.
• Support the QP and Supply Chain management by ensuring that issues and deviations are addressed in an appropriate and timely manner so that supply is maintained and disruptions minimised.

Full job description available on application

The Candidate

A confident and outgoing individual you will require:

• A degree in the Life Sciences as a minimum (higher degree desirable)
• A minimum of 10 years of relevant QA and GMP experience.
• Experience with injectable medicines and a qualification as a QP would be an advantage but not essential.
• A demonstrable understanding of the CMC aspects of regulatory affairs and their importance to product development, lifecycle maintenance and risk management.
• A clear understanding of the current and developing legislation and the ability to apply this to company Quality Assurance systems and processes.
• Outstanding communication skills with exceptional attention to detail – the ability to effectively communicate information, verbally and in writing, at levels appropriate to the needs of different internal and external customers.
• The ability to build and maintain effective working relationships with cross-functional and multinational colleagues including business partners and regulatory authorities.
• A proactive approach and strong critical thinking skills.
• A customer and solutions orientated mindset.
• Only candidates with existing right to work in the UK/EU will be considered