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Quality Manager, GMP/GDP, Home Based

Quality Manager, GMP/GDP, Home Based

Job Title: Quality Manager, GMP/GDP, Home Based
Contract Type: Permanent
Location: Home Based
Industry:
Salary: £Competitive
Start Date: ASAP
Reference: 15780 BT
Contact Name: Pharma Jobs
Contact Email: brian.tappy@nextphaserecruitment.com
Job Published: February 19, 2018 12:31

Job Description

Home based in the UK this is a brand-new opportunity to join an innovative pharmaceutical company at a key time in its development to support the launch of its first licensed product. The company is developing a number of exciting new products with the most advanced just being granted marketing authorisation. To support the manufacturing and distribution 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. All manufacturing and distribution activities will be outsourced the third party service providers hence the role can be home based.

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 integrated professionals backed by a strong, entrepreneurial management team. Having gained marketing authorisation for an initial product the company is now planning for the manufacturing, distribution and marketing later this year. 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/Supply Chain Manager 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 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.

 

 

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