Austin Vita is working with a fast-paced and dynamic CDMO with multiple sites across the UK. An exciting opportunity has arisen within this Pharmaceutical business for an experienced Head of Quality to join the Team.
As Head of Quality you will Manage multiple Groups across the business, including; QA Compliance, QA Product Release, Quality Control and Analytical Development. Ensuring that all products released from the site comply with regulatory and quality standards. Delivering a robust Quality Management System which meets customers and the regulatory agencies expectations. Working in conjunction to ensure the operation departments build Quality into their processes and organisations, and will be a key Member of the Site Leadership Team.
- Recruiting, training and developing the Quality Team
- Ensuring that all quality systems are managed appropriately , compliant to GMP and fit for purpose
- Ensuring that the QC Operations are managed in a way that ensures they are appropriately organised, equipped and resourced to provide agreed customer services levels, corporate and customer requirements and operational goals.
- Developing business strategies and tactical plans to drive the business in achieving its financial objectives within the Site Plan.
- Directing and controlling the activities of the stability function to meet regulatory and corporate standards and ensure the stability program is maintained so that marketed product is compliant to registered specifications.
- Implementing root cause analysis and other problem solving techniques within the business
- Managing the Product Release team which provides expertise required to develop quality systems and enables product release and facilitates continuous improvement.
- Managing the 'Qualified Persons' on the company's Manufacturing/Wholesale Dealer's licenses
- Maintaining personal expertise in UK/EU/USA regulations.
- Site Audits and Large Regulatory Inspections
- Managing the introduction of new products on to the site from a Quality perspective in conjunction with the Technical team
Knowledge and Experience:
- Science degree and at least 15 years relevant experience within pharmaceutical industry.
- At least 5 years at management level with demonstrated experience at senior level.
- An in-depth knowledge of the appropriate European US regulations and quality control techniques.
- Desirable to be a 'Qualified Person' (but not essential)
- Experience in Pharmaceutical Production.
You will be rewarded with a fantastic salary and benefits, so if this sounds of interest please apply ASAP.
Austin Fraser is acting as an Employment Agency in relation to this vacancy.
Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.
Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.