Quality Assurance Manager - Cell Therapy
An established biotechnology company is advertising a vacancy for a Quality Assurance Manager - Cell Therapy position based in Stevenage. The company develops next-generation, patient-specific therapeutics that allow scientists to combat cancer without harming healthy tissues. This is an exciting opportunity to work with a dynamic and revolutionary organisation.
- Supporting the Quality Director in build of QMS, ensuring activities conform with requirements.
- Performing 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
- Manage Product Specification Files for ATIMP's
- Reviewing and approving validation protocols and reporting and working with the manufacturing team to establish key manufacturing documentation.
- Selecting and implementing eQMS to support GxP activities and wider business.
Skills and Requirements:
- BSc or MSc in a chemical or biological subject.
- 7+ years' experience in developing and maintaining regulated quality systems.
- 5+ years' experience working in a pharmaceutical GMP or Medical equivalent environment.
- 3+ years working in Quality role on MIA/MIA IMP or HTA licenced site.
- Formal auditor qualification is desirable.
- DI experience is desirable.
- Thorough understanding of HTA requirements and Tissues and Cells Directive.
- A working knowledge of regulatory requirements that specifically apply for the manufacture and/or testing of cell therapy products and/or ATMP's.
- Good understanding of GCP requirements.
- Experience of training staff and building and managing small team.
- Experience with Clean room and facility design.
- Experience with Clinical manufacturing operations.
- Experience in ATIMPs and/or aseptically manufactured product.
- Experience in setting up and managing robust GxP compliant eQuality Management systems.
- Able to write/author SOPs, WIs and plans/reports to support clinical trial manufacturing operations.
- Demonstrable experience in planning, managing and executing vendors, raw materials, and site audits.
- Experience of working with third party contract manufacturing and testing organisations.
- Experience with Clean rooms and ISO14644 requirements.
- Demonstrable experience in Facility, Systems, and Equipment qualification activities.
- Technical expertise/knowledge of quality requirements for manufacturing processes and laboratory techniques.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Joshua Godden at +44 2038540101 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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