QA Manager/RP
I'm currently supporting a pharmaceutical organisation in Essex with the search for a Quality Assurance Manager to lead quality activities across GxP operations. This role would suit someone with strong GMP and GDP quality management experience, or is interested in stepping into a broader leadership role within a Pharmaceutical Quality System.
This is a key position within the quality function, responsible for overseeing quality systems, supporting regulatory inspections, and ensuring compliance across the import, storage, manufacture and distribution of medicinal products.
The Role
As QA Manager, you will take responsibility for maintaining and continuously improving the Pharmaceutical Quality System (PQS) while providing leadership across GxP-related quality activities. You will work closely with cross-functional teams to ensure regulatory compliance and support ongoing quality improvements across the organisation.
Key Responsibilities
* Provide quality leadership across GxP activities including the import, storage, manufacture and distribution of medicinal products
* Manage and continuously improve the Pharmaceutical Quality System (PQS)
* Oversee the self-inspection programme and support both internal and external GMDP audits
* Host and support regulatory inspections and customer audits
* Support site validation activities and maintain the Validation Master Plan (VMP)
* Manage supplier qualification activities and progress Quality Technical Agreements (QTAs)
* Review batch records to ensure QA requirements are met prior to certification by the Qualified Person (QP)
* Lead or support deviation investigations, change controls and root cause analysis
* Mentor and support the development of junior quality team members
Experience & Background
* Experience within Quality Assurance in the pharmaceutical or biotechnology sector
* Strong working knowledge of GMP and GDP regulations
* Experience operating within Quality Management Systems (QMS) or Pharmaceutical Quality Systems (PQS)
* Previous involvement in deviation management, change control and investigation processes
* Experience supporting regulatory inspections and audits
* Excellent attention to detail and the ability to work collaboratively across departments
Package
* Salary: £Comp
* Location: Essex
* Sector: Pharmaceutical / Life Sciences
Apply
If you're interested in learning more about this opportunity, please get in touch to discuss the role in more detail or to submit your application.