QA Manager, GMP/GDP, Home Based, UK

Home based in the UK, this is a “green field” opportunity to join an innovative pharmaceutical company at a pivotal time in its development. The company had developed a number of exciting new products which are completing successful clinical trials and awaiting marketing authorisations. To support the manufacturing and marketing of these first products a new Quality Manager position has been created to bring the full range of GMP and GDP expertise into the company. This will be a broad role at QA function ownership and hands-on levels while acting as the companies GMP QA SME.

The Company

The company is a specialty based pharmaceutical organisation that benefits from substantial backing and is listed on the AIM stock market. It operates as a “virtual company” with a core of highly committed and integrated professionals backed by a strong, multi-skilled entrepreneurial management team. Having developed a number of initial products through to successful clinical trials the company is now planning for the manufacturing, distribution and marketing of these new innovative solutions. It also boasts a strong pipeline of further products in pre-clinical and clinical development to back its goals of long term sustainability through innovation. 

The Role

This is a brand new, and key strategic position to bring GMP and GDP expertise into the company. The role will be responsible for the quality and compliance of the Quality Management System (QMS) and development/commercial activities related to GMP/GDP. The GMP/GDP Quality Manager will report to the Head of Quality and support the Responsible Person in all aspects of the QMS. Specific responsibilities will include the review and approval of development and commercial GMP/GDP documentation, review and approval of Quality Technical Agreements with CMOs, review and assessment of supplier quality metrics, oversight of GMP/GDP SOPs, ensuring harmonisation across GxPs in relation to continued development and innovation plus ensuring the business is driven by continual improvement in quality through robust CAPA processing and change control. In addition the job holder will plan, prepare and conduct GMP/GDP audits of suppliers while maintaining constant audit readiness to successfully host regulatory agency inspections. This role will cover products in going into commercialisation as well as drugs in clinical trials. 

A full and detailed job description is available.  

Experience

We are seeking a highly experienced GMP/GDP professional capable of establishing themselves in this position while driving the standards for this new function and acting as the company SME. You will need 5 to 10 years relevant QA experience and be capable of working at QA ownership/strategy and hands-on levels. Your expertise will cover all aspects of GMP/GDP documentation, QMS ownership, SOP management, CAPA tracking, process improvement, auditing and training/mentoring. In addition you should be used to working with, and having oversight of, external suppliers including CMOs.

This is a permanent position.