Uk Head of Quality

2 weeks ago

Abingdon, United Kingdom Adaptimmune Full time

**About Us**:Adaptimmune is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immunotherapy products for people with cancer. The Company's unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors.

Our company culture is rooted in trust, inclusion, our capacity to collaborate, and our commitment to being honest and brave in our desire to successfully transform the lives of people with cancer.

**About the Team**:Our Quality team ensures the utmost quality and compliance across Adaptimmune and fosters an environment of partnership and collaboration where everyone is responsible for quality. Ensuring everything is right the first time, every time is our mission. As a member of the Quality team, you become a part of a diverse and inclusive global organization which maintains quality oversight for every aspect of the manufacturing process from start to finish. This includes, but is not limited to, raw materials, vector, supplier quality, audits and inspections, training, quality systems, quality operations, quality control, contract testing labs, and contract manufacturing organizations. Come join a team where our patients are at the center of everything we do and where quality leads the way

**PRIMARY RESPONSIBILITY**

The UK Head of Quality will strategically lead all B39 quality functions supporting the Adaptimmune clinical pipeline with a focus on GMP manufacture of genetically modified iPSC-derived allogeneic T-cells, QP importation certification of autologous products, the Stevenage Vector Facility, and the QCAM organization. This role reports to the Vice President Global Quality who is based in the US. The Head of UK Quality will actively manage Adaptimmune’s Qualified Persons (QP) and manufacturers licenses as part of his/her duties. The UK Head of Quality will strategically lead all B39 quality functions supporting the Adaptimmune clinical pipeline with a focus on GMP manufacture of genetically modified iPSC-derived allogeneic T-cells, QP importation certification of autologous products, the Stevenage Vector Facility, and the QCAM organization. This role reports to the Vice President Global Quality who is based in the US. The Head of UK Quality will actively manage Adaptimmune’s Qualified Persons (QP) and manufacturers licenses as part of his/her duties.

**KEY RESPONSIBILITIES**
- As the Quality primary point of contact for the UK, the Head of UK Quality is the primary decision maker in with a scope that includes, but is not limited to, lot release, GMP documentation, quality risk management, lifecycle management, validation, qualification, internal and external auditing processes, and data integrity.
- Oversee and monitor Quality standards as required; identify and drive continuous improvement.
- Responsible for lot release. Ensure that all products released from Adaptimmune UK meet UK (MHRA), US (FDA) and European (EMA) standards of strength, identity, safety, purity, and quality (SISPQ).
- Responsible for managing all regulatory inspection activities in B39 and Stevenage in support of ongoing clinical trials as required. Overall responsibility for UK MIA(IMP) license.
- Establishment and maintenance of an integrated quality culture.
- Partner with Operations and QC to ensure appropriate quality of phase-specific products or testing, alongside growth of the product lifecycle.
- Lead the quality considerations for new facilities, process, and equipment to ensure compliance to cGMP
- Work directly with the Philadelphia site for the manufacture of autologous product requiring QP certification in the UK from B60 via Adaptimmune QPs, and through third parties requiring QP certification in the EU.
- Support the Adaptimmune network of GMP manufacturing facilities in the US and UK as needed with advice, strategy, decision-making etc.

**QUALIFICATIONS & EXPERIENCE**

**Required**
- Degree in science or engineering.
- Must have significant experience in managing a quality function including direct experience supporting technology transfer and manufacturing activities.
- Proven track record managing quality functions in a regulated environment.
- Extensive knowledge of regulatory compliance for advanced therapies, lot release, and quality systems.
- Establishing data integrity systems

**Desirable***
- Registered Qualified Person (QP) as per The Humans Medicines Regulation 2012 (as amended)
- Proven track record supporting complex process validation strategies for biologics, vaccines, or autologous/allogenic products.

**SKILLS & COMPENTENCIES**
- Excellent/accomplished communication, negotiation, facilitation, influencing, and strategic thinking skills.
- Must be detail oriented; must be precise and organized in handling of documents.
- Must be able to prioritize multiple tasks.

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