Strategic Quality Lead, Qualified Person

The Healthcare Quality Assurance (QA) Strategic Quality Lead, and Qualified Person (QP) is responsible for the oversight of the Marken and Polar Speed Quality Management System (QMS), Standard Operating Procedures (SOPs), processes and policies required to manage and control storage, distribution, and production facility. With regional oversight support the GMP depots and practice quality requirements, and meet Marken and Polar Speed, our clients and regulatory agency expectations.,

Ensure that any activity (storage, additional labelling, quality control, release, distribution, returns, rejects and destructions, related to investigational medicinal products and starting materials is performed in compliance with European and regional regulations and good manufacturing/distribution practices, by means of operating an effective QA system.

QP certification of pharmaceutical, clinical trial materials in accordance with IMPDs, PSFs and EU GMPs as well as taking any other QP responsibility as per GMP guidelines for Polar Speeds depot in Leighton Buzzard.

Support the head of production for the important IMPs in your area of expertise and for Marken in house manufacturing as necessary.

Host regulatory inspections and manage the regulatory audit report response's.

Liaise with all clients on all QP matters.

Prepare an external audit programme and perform audits of external service providers as part of the vendor selection process or of the clients supply chain as required to meet personal knowledge requirements for QP certification.

Provide Quality leadership and oversight of the QP team to ensure consistent implementation o and compliance to the Marken and Polar Speed Quality Management System at all locations in the assigned region.

Supports growth of new and expanded facilities, clients and services.

Communicate and maintain the Marken and Polar Speed Quality plan.

Ensure targets are achieved through effective quality performance monitoring, measurement, and analysis and reporting. This may include working specific hours and change in shift pattern.

Bachelor's degree or International equivalent in Sciences
- Required

Degree qualified within a scientific related discipline and recognised as a Qualified Person in accordance with Regulation 36 of the Human Medicines Regulations 2012 (SI 2012/1916)

Pharmaceutical, healthcare or food industry experience - Preferred

10 plus years o relevant experience working in a Qualified Person role within GSP/GMP/GDP regulated position

Deep knowledge and understanding of GMP,GDP, AND ISO Compliance

ASQ or ISO Certification preferred