Senior QA Specialist - Sterile Biopharmaceutical GMP

Senior QA Specialist - Sterile Biopharmaceutical GMP

Job Title: Senior QA Specialist - Sterile Biopharmaceutical GMP
Contract Type: Permanent
Location: Stevenage
Salary: Excellent Salary + Benefits
Start Date: 2019-06-12
Reference: J16018t
Contact Name: Steve Twinley
Contact Email:
Job Published: June 13, 2019 07:58

Job Description

Are you a Pharmaceutical QA professional with leadership and training skills, as well as the ability to take charge of a range of Quality-related projects? A series of new positions has been created in Stevenage, Hertfordshire, to join a genuinely exciting and unique organisation in the manufacture of Advanced Therapy Medicinal Products and Gene Therapies to treat cancer. You will have leadership responsibilities within a small QA team and have significant input into developing a QMS for GMP in a multi-product facility that delivers cell and gene therapies for clinical trials.
The company is offering an excellent salary and benefits package (to discuss on application) and this will be a great opportunity to progress your career within a growing business. If you have a background in QA for sterile manufacture, together with a life science degree, we would love to hear from you.
The Role 
This is a varied and exciting role which will include the following: 

  • Line management and training of QA colleagues
  • Review and qualification (or disqualification) of starting material and critical raw material suppliers, including audits and desk-based reviews
  • Continuous improvement of the Pharmaceutical Quality System (PQS)
  • Operator training and competency assessment systems
  • Process qualification and validation, including sterile processes
  • Analytical and Quality Control assay validation
  • Manufacturing authorisation management, including GMP licence variations
  • Clinical Trial Authorisation management, including amendments to IMP dossiers
  • Drug Product release following batch certification
  • Retention and reference sample management and control of release for use in investigations
  • Real-time review of Batch Manufacturing Records and Quality Control records
  • Conducting self-assessments in accordance with a defined schedule
  • Deviation management, including coordinating change controls, quality exceptions, microbiological out-of-trend and out-of-specification results
  • Equipment and facilities validation and revalidation protocols
  • Assessment and qualification / disqualification of raw material suppliers, including audits
  • Auditing of GMP contractors conducting outsourced activities
  • Product Quality Review
  • Risk assessments with respect to product quality and health and safety

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.
In addition to a competitive salary (negotiable depending on experience), the company offers a very good benefits package including:

  • 25 days annual leave
  • Excellent pension scheme
  • Life assurance (4 times basic salary)
  • Group Income Protection
  • Private Medical Insurance (paid for by the company for yourself only)
  • Eye care vouchers
  • Excellent career prospects, including advanced training (potentially QP training) 

The successful candidate will have a PhD, MSc or BSc in Pharmaceutical Sciences, Biology, Immunology or similar, combined with significant QA experience gained in a commercial GMP / sterile Biopharmaceutical manufacturing facility. A strong understanding of sterile operations and practices would be a big 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 highly advantageous, as is having expertise in the manufacturing and testing procedures for advanced therapies.
Full details will be provided on application. Apply now!