Manager, Quality Assurance Lot Disposition

4 weeks ago

Philadelphia, United States Adaptimmune Full time
Job DescriptionJob Description

Adaptimmune is a fully integrated cell therapy company, designed and built from the ground up with four U.K.- and U.S.-based biotechnology hub locations. Our comprehensive capabilities and teams include preclinical research, clinical development, translational sciences, autologous and allogeneic manufacturing, and in-house commercial and corporate operations.

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.
 

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

Quality Assurance and Quality Control are responsible for the timely testing, review, and release of life-saving medicine.  The Quality team has a hand in all matters relating to manufacturing, routine batch testing, regulatory updates/requirements, process development, stability/raw material control, and much more.  Being on the team at Adaptimmune allows an individual to fully immerse themselves into a clinical trial from the initiation via a new IND all the way through to a commercial manufacturing product.

Primary Responsibility

The Quality Assurance Manager is responsible for facilitating and ensuring the timely release of products through the management quality assurance functions. Those functions may include but is not limited to the oversight and approval of laboratory protocols and reports, data review, batch record review, deviations, product complaints, change controls, and CAPAs using the quality management system.  The QA Manager may also support calibration and validation document reviews when necessary. The QA Manager role is a key leadership role responsible for leading a team of QA specialists to ensure products are delivered on time and to drive continuous improvement. 

Key Responsibilities

  • Oversee the review and approval of quality control method validation protocols and testing data, stability protocols and reports, and raw material data forms and specifications. Perform other quality assurance tasks as needed.
  • Ensure timely completion of documents requiring quality assurance approval which may include Standard Operating Procedures, Work Instructions, Deviations, CAPAs, Change Controls, Complaints, and Validation Protocols and Reports (including coordinating, providing quality guidance, and performing risk assessments).
  • Manage the receipt and processing of Supplier Change Notifications.
  • Manage the receipt, investigation, and closure of Product Complaints, Supplier Complaints and Adverse Events.
  • Develop and optimize Quality policies, procedures, work instructions and guidance documents required to support clinical and commercial production.
  • Manage timely release of raw materials and consumables to maintain the production schedule.
  • Work with cross-functional groups to develop and approve raw material specifications. Support development of clinical/commercial label specifications/templates and final T-Cell drug product release Specifications.
  • Provide and present KPI metrics for quality activities to leadership teams for quality council meetings.

Qualifications & Experience

Required

  • Minimum of 8-10 years working in a biotech or pharmaceutical environment.
  • BS in a scientific discipline.
  • Excellent verbal and written communication skills.
  • Thorough knowledge and understanding of quality requirements for clinical and commercial manufacturing processes.
  • Thorough knowledge and understanding of cGMP, ICH, FDA/EMA, and other global guidance’s/regulations.
  • Thorough knowledge and understanding of Quality Systems.
  • Working knowledge of root cause analysis tools and CAPA plans to address product impact.
  • Ability to lead project teams and work collaboratively to drive right the first-time initiatives.
  • Ability to identify and implement continuous process improvements.
  • Ability and desire to effectively work in an interdisciplinary team environment and to effectively interact at multiple levels within the company.

Desirable

  • Previous quality assurance experience working in a cell therapy firm.
  • Ability to build and lead a high performing organization.
  • Previous experience working collaboratively with CMOs and Qualified Person in the UK and EU.

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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