Paramount Recruitment

+44 (0)121 616 3460

+44 (0)121 616 3460

+1 833 455 3043

+1 833 455 3043

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Quality Assurance Manager – Cell & Gene Therapy- Hertfordshire

Quality Manager – Cell Therapy- Hertfordshire

A fantastic opportunity has arisen for a Quality Manager to join an expanding and truly cutting edge company based in Hertfordshire. As an organisation their science is ground-breaking and they are looking for the next phase of talented scientists to further build on their highly successful growth phase

As the Quality Manager you will join the expanding manufacturing team to support the scale up of manufacturing cell therapy products. You will play a key role in establishing, growing and maintaining the quality systems and processes to support the expansion of operations for GMP production.

Key responsibilities:
*Support Quality Director in building the quality management system
*Perform routine QA duties to ensure GMP & HTA compliance plus other regulatory requirements relating to manufacture of Autologous ATIMPs including:

-document control system
-change controls
-corrective and preventative actions (CAPA)
-deviation & out of specification (OOS) reporting
-complaint and recall handling
-calibration and maintenance
-qualification & validation
-internal and external audits including vendor /supplier qualification
-batch record review prior to QP certification
-Draft, review and approve Quality and GxP related documentation

*Reviewing and approving validation protocols and reports and working with the manufacturing team to establish key manufacturing documentation
*Selection and implementation of eQMS to support GxP activities and wider business
*Key input into QMS policies and plans

Experience required:

*BSc/Msc in a life sciences subjects
*Extensive experience in developing and maintaining regulated quality systems.
*7+ years’ experience working in a pharmaceutical GMP or Medical equivalent environment
*5+ years working in Quality Assurance role on MIA/MIA IMP or HTA licenced site
*Experience in ATIMPs and/or aseptically manufactured product
*Experience in setting up and managing robust Quality Management systems
*Experience with Clean rooms and ISO14644 requirement

This is a unique opportunity to join a company in an exciting start-up phase and to lead a new core team who will play a vital role in scale-up and expansion of manufacturing. In return the company are offering a fantastic package including share options and bonus. There is also plenty of opportunity for career development and growth. To find out more about this superb opportunity please contact myself, Lauren Gripton, of Paramount Recruitment on lgripton@pararecruit.com

Keywords- atmp, atmps, gene therapy, cell therapy, cell therapies, cellular therapies, gmp, good manufacturing practice, production, manufacturing, manager, quality control, QC

Paramount Recruitment Limited provides services as an agency and an employment business. We regularly have similar roles in this area. Please see our website for details or send your CV in to us to find out the latest opportunities. By applying for this position you agree to our privacy policy which can be found here: https://www.pararecruit.com/legal/privacy-policy/

Job Reference: Lg23564_1573827361

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Salary To: Negotiable

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Recruitment Consultant: Lauren Gripton

Recruitment Consultant

Lauren Gripton

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