The Sr. Manager, GxP Training position is responsible for managing Sarepta's global GxP Training System. The position will work in a hybrid manner (remote & on-site, located in the Andover, MA facility), reporting to Quality Systems in QA Compliance. The position encompasses oversight of all GxP wide training processes and programs (GLP/cGCP/GCLP/ GVP/GMP/GDP - Distribution) in accordance to US and International guidelines and regulatory requirements. The GxP Training System involves administration of Sarepta's electronic Training LMS, establishment of role-based curricula, development of suitable training content creation and training delivery based on specific GxP work/scope being performed, which is divided amongst the training team. This position will ensure management and oversight of the GxP Training program and serve as the primary training SME for all cGMP/GDP (commercial & distribution) related training needs, providing subject matter expertise, guidance, and training to applicable personnel. The role will assume responsibility for collaborating cross functionally to ensure GxP personnel at Sarepta are adequately trained and qualified. This role will work closely with QA Compliance / Quality Systems personnel to ensure sustained GxP compliance across Sarepta's Quality Management System.
Primary responsibilities will include the following:
Manage the GxP Training System in accordance to global regulations; implement/revise training processes, procedures and documentation to ensure compliance, agility & fit for purpose
Identify, develop and ensure GxP training program content for Sarepta quality business processes, compliant to GxP Quality Management System
Identify training requirements/gaps within the GxP functional areas, coordinate and institute improvements
Provide and coordinate training to personnel (e-learning and live training sessions); serve as cGMP/GDP SME and train on various topics (e.g., compliance fundamentals, QMS processes, training processes; new hire onboarding, good documentation practices, data integrity, annual refreshers, etc.)
As GMP Training SME, develop cGMP/GDP training courses and materials, including the creation of internal SCORM training materials tailored to Sarepta's internal processes and business needs
Establish & maintain GxP course curriculum and role-based training requirements; partner with functional areas to assure assignments are based on a person's actual job function and responsibilities
Administer Sarepta's electronic Training LMS; become a business administrator, power user and core team member to replace Sarepta's existing LMS system with a new Training LMS (Veeva Training Vault)
Partner with the GxP Training Team to co-manage global training programs, including the Trainer Qualification (Train the Trainer) Program and Training Coordinator Program; leverage internal resources to support Sarepta's training needs and goals
Oversee OJT (On the Job Training) Program and implement OJT Courses for cGMP/GDP critical processes having direct product/patient safety impact; establish suitable methods for delivery and effectiveness
Assure GxP training calendar, course catalog, and Training Intranet site content is maintained/current
Obtain and control GxP personnel job descriptions and CV information; oversee annual review activities
Serve as a training SME during audits/regulatory inspections; assist in inspection preparation and ensure the Training Program is 'inspection ready' at all times
Monitor training performance and provide KPI matrices/reports to management; drive continuous improvement activities
Support training projects and provide cross functional backup support within the Quality Systems Team as assigned
Participate in team/company initiatives as assigned in support of achieving Sarepta's goals
Education and Skills Requirements:
Bachelor's Degree or higher in a scientific discipline preferred
Minimum 10 years' experience in a similar training management role within the Life Sciences industry; Global experience and previous supervisory experience preferred
Understanding GxP Quality Requirements, expertise in cGMP/GDP required, including extensive knowledge of 21CFR Parts 210 and 211
Experience administering an electronic Training LMS is required; Veeva experience a plus
Advanced computer skills utilizing MS Office Products and SCORM authoring tools (Articulate/Adobe Captivate) required
Change agent & compliance advocate personality; identifies continuous improvement opportunities and drives innovation with limited guidance or support from upper management
Strong team player with demonstrated track record of success in a cross-functional team and fast paced environment; can easily adjust workload and make decisions in support of shifting priorities
Excellent organizational, computing and oral/written communication skills
Ability to influence and negotiate effective solutions