A brand-new position in Stevenage for a Senior QA professional with leadership experience, a life science degree or higher (Pharmaceutical Science, Immunology or similar) and significant industrial experience in a Quality-based role. You will join a genuinely exciting and unique organisation involved 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 and this will be a great opportunity to progress your career within a growing business.
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.
This is a varied and exciting role which will include the following:
- Line management and training of less experienced 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 Investigational Medicinal Product 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 within a PQS including coordinating change controls, quality exceptions, microbiological out-of-trend and out-of-specification results and other environmental excursions
- Equipment and facilities validation and revalidation protocols
- Assessment and qualification (or disqualification) of raw material suppliers, including audits
- Audits of GMP contractors conducting outsourced activities
- Product Quality Review
- Risk assessments with respect to product quality and health and safety
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
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.
Full details will be provided on application. Apply now!