The Associate Director Quality provides leadership and technical guidance to the Adaptimmune staff regarding Good Manufacturing Practice (cGMP). Following Adaptimmune Quality Policies and Procedures, the Associate Director Quality leads the activities related to material release, Quality investigations, auditing, change control, batch record review, CAPA, documentation management & creation, raw material, in-process and final material release, equipment qualification and product lifecycle documentation. The role has accountability for the overall management of the quality function at the Stevenage facility, is responsible for decision on the disposition for manufactured lots.
The position will be making tactical decisions including batch disposition, documentation approval, SOP development and approval, qualification and validation, and interacting with regulators. The position will lead the strategy for the quality development for the facility and the interaction with other departments.
The role is based in Stevenage at the manufacturing facility. In addition, the candidate must be willing to travel locally to the UK headquarters in Milton Park, Oxfordshire and internationally to contract service providers or suppliers as required. Initial travel approximately 10% reducing to 5% after ~3-6 months
- Prepare, review and approve master batch records, procedures, validation documentation, specifications, reports and forms.
- Initiate improvements to the Quality Management System, ensuring compliance to all relevant Quality Standards and regulatory requirements
- Manages overall lot release process to ensure clinical requirements are met; Conducts record review of executed batch records for vector lots. Assures all Quality events, change controls, CAPAs and/or other required documentation related to the material lots are completed and closed prior to material/lot release.
- Review and proactively assist in process capability studies and statistical techniques as necessary, to support continuous improvement. Initiate updates/tracking on status of Quality Events and CAPAs as appropriate.
- Participate as cross-functional team member for process verification and technical transfer projects. Lead the product lifecycle documentation requirements.
- In conjunction with MS&T & Manufacturing, evaluate Quality Events / Non-Conformances. Support the identification of corrective and preventive actions; determine assignable root cause, complete failure investigations and follow up to corrective and preventive actions, ensuring adequate and timely closure.
- Participate in the development and maintenance of Adaptimmune’s Quality System to meet the requirements of the relevant regulatory authorities, Notified Bodies (if applicable) and ISO standards (as applicable) and all other applicable quality and regulatory standards.
- Prepares and issues certificates of compliance (CoC) and certificates of analysis (CoA) as required for manufactured materials; Audits vendor certificates (e.g. CoA, CoC) for completeness and compliance against approved specifications. Evaluates lot test results against trending data to identify any irregular behaviour.
- Evaluates environmental monitoring results for conformance with ICH/GMP requirements in support of lot release.
- Assists in the audits of contract manufacturers and contract laboratories for GMP compliance as required
- Support in the preparation for regulatory submissions and inspections, as needed.
- Owns the equipment requalification and aseptic process validation programs
Qualifications & Experience
- Degree in a scientific discipline.
- Hands-on experience in bio/pharmaceutical operations within quality operation roles.
- Detailed knowledge of Quality Systems, such as Change Control, Investigations, and CAPA
- Direct experience supporting development and technology transfer activities.
- Excellent technical writing skills including SOPs and investigation reports
- Knowledge of regulatory compliance for biologics manufacture, lot release, and quality systems (FDA/EMA).
- Qualified Person (QP)
- Knowledge of ATMP manufacture, especially viral production.
Skills & Compentencies Required
- Demonstratable leadership skills and experience
- Able to communicate to other departments and within an organisation effectively
- Able to manage multiple priorities
- Excellent problem solving skills
- Able to exercise judgment to determine appropriate corrective actions following events
- Strong attention to detail