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.

PRIMARY RESPONSIBILITY

The Specialist, Global GMP Training, is responsible for managing the QA training system and for the development and delivery of the GMP training curriculum for new hire and annual training. Supports the training program for the Global GMP organization with a focus on developing GMP training solutions that are effective and efficient and set the standard for development, execution, and continuous improvement. This includes training plans, training needs analysis, training materials design/development/delivery, and evaluation of training effectiveness.
Collaborates with Global groups to ensure business objectives are met through effective learning solutions; administers, oversees and organizes job specific training programs for the GMP organization.
Forms a global partnership with other area training representatives to harmonize ideas, practices, and processes to ensure an aligned approach across the greater Adaptimmune organization.

KEY RESPONSIBILITIES

Schedule, communicate, conduct & document GMP, Good Documentation & Aseptic Behavior TrainingLiaison with functional business units to develop and continuously improve department training and qualification programsAssess Adaptimmune GMP training program and documents for complianceSupport training compliance in site Learning Management Systems (Master Control & Veeva)Support BLA/PAI/Internal or External Audits

QUALIFICATIONS & EXPERIENCE

Required

Bachelor’s degree in education, science, engineering, or related discipline.Minimum of 5 years firsthand experience in GxP training bio/pharmaceutical operations, technical operations, and/or quality operations.Knowledge and application of Adult Learning Theory and training analysis, design, development, implementation, and evaluationKnowledge and application of computer-based learning management systemsKnowledge of Quality Management Systems and Continuous Improvement methodologiesExtensive knowledge of GMP, ICH and FDA/EMA regulationsExcellent technical writing skills including but not limited to SOPs, Deviations, Change Controls & Reports

Desirable

Demonstrated knowledge of electronic DMS (Document Management Systems) & LMS (Learning Management Systems)
OTHER REQUIREMENTSMinimal travel both within and outside the USSome physical movement of document files/boxes may be required

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.