Associate Director, Quality

at  Adaptimmune

QUALIFICATIONS & EXPERIENCE

Required

• Degree in a scientific discipline.
• Hands-on experience in pharmaceutical industry within quality 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.

Desirable

• Qualified Person (QP) or trainee
• Knowledge of manufacture of biological drug substances/ products or ATMP

At Adaptimmune we embrace diversity and equality of opportunity. We believe that the more inclusive we are, the better our work will be. We welcome applications to join our team from all qualified candidates, regardless of age, colour, disability, marital status, national origin, race, religion, gender, sexual orientation, gender identity, veteran status or other legally protected category. It is our intent that all qualified applicants will receive equal consideration for employment.
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• Ensure a GMP compliant Quality System is in place to support manufacturing with site responsibility for systems including deviation, CAPA, training, material release, batch release, environmental monitoring, validation status and internal audit. Oversee quality assurance department (operations, system and validation) and performance for the Stevenage site.
• Oversee and participate in the preparation, review and approval of master batch records, procedures, validation documentation, specifications, reports and forms.
• Manage the lot release process to ensure clinical/ commercial requirements are met via review of executed batch records for vector lots. Assure 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.
• Participate as a cross-functional team member for process verification and technical transfer projects.
• Lead the product lifecycle documentation requirements.
• In conjunction with MS&T & Manufacturing, evaluate 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 Global 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.
• Apply product & process Lifecycle Management principles to ensure compliance with required standards for clinical to commercial manufacturing of lentiviral vector in collaboration with the validation department. Own the equipment requalification and aseptic process validation programs as relevant to the site.
• Assist in the audit of contract manufacturers and contract laboratories for GMP compliance as required. Assure appropriate oversight of external (GxP) activities, including vendor qualification, establishing and maintaining Quality Agreements, supplier performance monitoring, support audits and tracking CAPA follow-ups.
• Oversee and participate in the preparation and issue of 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.
• Ensure appropriate communication, oversight and compliance within the Catapult Cell and Gene Therapy Manufacturing Centre quality management system including evaluation of environmental monitoring results for conformance with ICH/GMP requirements in support of lot release.
• Support in the preparation for regulatory submissions, site inspections and overall inspection readiness at site.
• Ensure adequate resourcing of quality for the site. Develop budget plan to support quality and compliance development
• Interface with senior management to discuss quality and compliance issues. Communicate effectively with Senior leaders project plans, compliance risks and mitigations.