Senior QA Specialist - Biotech GMP

Senior QA Specialist - Biotech GMP

Job Title: Senior QA Specialist - Biotech GMP
Contract Type: Permanent
Location: Stevenage
Salary: Competitive
Start Date: 2019-11-25
Reference: V-45982
Contact Name: James Hume
Contact Email:
Job Published: November 25, 2019 13:30

Job Description

A further opportunity based in Stevenage for a Senior QA professional to join a genuinely exciting and unique organisation involved in the manufacture of Advanced Therapy Medicinal Products and Gene Therapies to treat cancer. 

As a Senior QA Specialist, you will have leadership responsibilities within a growing QA team and have significant input into developing and maintaining a QMS for GMP facility that manufactures cell and gene therapies for clinical trials. 

You will be leading a wide range of responsibilities such as the review and qualification (or disqualification) of starting material and critical raw material suppliers, including audits and desk-based reviews.  As well as continuous improvement, training, process and equipment validation, GMP license variations, Clinical Trial Authorisations, Drug product release and review of Batch Manufacturing Records.  As part of your day to day work, working autonomously with ownership of these functions. 

In a leadership capacity where you will have the responsibility for more junior members of the team conducting self-assessment, deviation management including change controls, out of trend and out of spec, audits, raw material assessment, risk assessments and equipment and facilities validation. 

The responsibilities listed here are some examples but not the full remit, with the Senior QA specialist being involved in the majority of day to day QA functions along with additional strategic responsibilities.

PLEASE NOTE: this is a 12 minth fixed term contract

The successful candidate will have a PhD, MSc or BSc in Pharmaceutical Sciences, Immunology or similar, combined with significant QA management experience gained in a commercial GMP / sterile Biopharmaceutical manufacturing facility. A strong understanding of sterile operations and practices would be a strong advantage. You will need to have excellent people skills, the communication to communicate with colleagues and external partners at all levels, and first-rate organisational skills. Experience with MHRA and HTA inspections (either as a host or involved contract giver to a manufacturing site) is essential, as is having expertise in the manufacturing and testing procedures for advanced therapies.
PLEASE NOTE: This is a 12 Month Fixed Term Contract
The Company
A pioneering and ambitious Biopharmaceutical company who develop next-generation, programmed T-cell therapies to treat cancer. The organisation has existed for 4 years and is very well funded, with a clear strategy and expansion plan for the next 3 years and beyond. Scientifically, the company has extremely exciting technologies, using a broad suite of proprietary and modular T-cell programming to engineer precisely targeted, controlled and highly active T cells. Commercially, they have a pipeline of product candidates in development (for the treatment of haematological malignancies and solid tumours) and is increasing its GMP / sterile production capacity. Based in a state-of-the-art facility in Stevenage, Hertfordshire, you will join a team that is doing something genuinely meaningful.