Associate Director, Quality in Stevenage

Location: Stevenage

Salary: Hidden

Recruiter: adaptimmune

Job Hours: Full-time

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PRIMARY RESPONSIBILITY

The Associate Director Quality provides leadership and technical guidance to 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 and is responsible for decisions on the disposition of manufactured lots.

KEY RESPONSIBILITIES

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.

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

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About adaptimmune

adaptimmune.com

Adaptimmune, a leader in T-cell therapy, is a multinational, clinical-stage biopharmaceutical company focused on developing novel immunotherapies using its proprietary SPEAR T-cell receptor platform to treat solid tumors, which has the potential to transform the treatment of cancer.

Our proprietary SPEAR T-cell platform has generated a strong pipeline of affinity-enhanced T-cell therapies, with multiple INDs open. We use these therapies to harness the body's own immune system to find and destroy diseased cells. Our SPEAR TCR therapies offer promise to patients that often have no other options. We are working hard to make that promise a reality.

We are based in the UK, in Oxford, and in the US, in Philadelphia. For more information about Adaptimmune, please visit www.adaptimmune.com. If interested in joining our fast growing team, click on the careers tab of this page.