Head of Quality Assurance

Our client is an established pharmaceutical company looking to add a Head of Quality Assurance to head up a Quality department on-site in Cheshire. The Head of Quality will promote and integrate quality into every aspect of the business ensuring GMP compliance and meeting regulatory authority's expectations.

The role holder will perform all duties required of a site leader to the Quality Teams, improve the QMS, provide expertise and guidance on changing regulatory landscape and input into operations that protect company reputation whilst maintaining product safety and supply to the market. The role holder will be named as Qualified Person on Manufacturer and Importer Authorisations therefore QP status is required. This is a fully site-based role managing a QA department and team.

The Role:

1. Work with and manage the Quality team to enable the efficient evaluation and release of pharmaceutical and medicinal products.
2. Work closely and effectively with other departments such as Regulatory Affairs, Compliance, Validation, Sales, and Logistics to maintain the highest quality and compliance standards and ensure product supply to market.
3. Act as Qualified Person to the business - managing contract QPs and a QA team via middle managers.
4. Host regulatory inspections for the business and provide support to the group for regulatory inspections and conduct self-inspection and audit programs.
5. Oversee the Pharmaceutical Management System.
6. Implement GMP regulations and industry best practices, where applicable.
7. Support and develop the QA team and improve on best practices and current SOPs.
8. Lead manufacturing deviation and test out-of-specification / out-of-trend investigations.
9. Audit the contract manufacturing organisation and laboratory against EU GMP and relevant regulations and guidelines with the support of the wider team.

Qualifications and Skills:

1. Qualified Person (QP).
2. Experience in the manufacturing and testing of oral dosage forms and topical products.
3. Experience in releasing medicinal products in a fast-paced environment.
4. Management of a QA team.
5. Stakeholder Management - internal/external.
6. Relevant education or proven track record in a similar position.