Salary: High Basic Salary and excellent benefits package
Our client, a highly recognised, global business committed to the development of Advanced Therapeutic Medical Products is currently looking to recruit a talented Quality Manager with responsibility for managing the Quality Assurance processes across all UK sites. The role will be primarily based at the UK Manufacturing site but will also cover R&D and Laboratory based facilities.
As the Quality Manager, responsibilities will include (but not be limited to):
Responsible point of contact for Quality related activities as required by Quality Technical Agreements with all contract partners
Responsible for the development of the UK Quality Management System
Performing all day to day QA duties to ensure manufacturing, testing and clinical trials activities comply with GMP, GCLP, GCP, HTA and other regulatory requirements relating to manufacture and clinical trials for relevant therapeutic products including;
Document control system
Corrective and preventative actions (CAPA)
Deviation & OOS reporting
Complaint and recall handling
Calibration and maintenance
Qualification & validation
Vendor qualification including external audits as necessary
Batch record review prior to QP release
Draft, review and approving Quality and GxP related documentation
Advising all manufacturing and R&D teams on Quality related issues
Informing VP Quality and Senior Management of significant quality related matters or risks that could impact product quality, product release or regulatory compliance.
Promoting quality culture with local team
Organizing training of UK site personnel and delivery of basic GMP training
Assisting in any Quality related issue on other company sites globally
The successful candidate will possess:
A University degree in a biological science, pharmacy, chemistry or equivalent
Minimum of 8 years experience working in a GMP environment (preferably in particular small scale e.g. clinical trials or manufacturing individualised patient products.)
Min 5 years experience working in a Quality related environment
Significant experience of writing and/or review of GxP documents (SOPs, qualification/ validation reports and batch records) to ensure good documentation practice and essential GxP, Quality and regulatory requirements are met
A good working knowledge of EU GMP
A good working knowledge of cleanrooms, aseptic technique and hygienic requirements for sterile products
Solid working knowledge of using Microsoft office programs
This opportunity represents an excellent opening for an experienced, self-motivated Quality Manager to take on a responsible and rewarding role in an exciting, niche area of Life Sciences.
If you are interested in this opportunity Please call Jim Maddison at Scientific Professionals on +44 (0) 207 822 1710 or send an updated version of your CV via email to firstname.lastname@example.org
Not quite the right role for you? We do operate a generous bonus referral scheme should we go on to place anyone that you recommend to us so please feel free to pass these details forward.