What are the responsibilities and job description for the QA Systems Manager position at Priovant Therapeutics?
Overview
Priovant is committed to developing therapies that address high unmet need in autoimmune disease. The QA Systems Manager will help advance this mission by coordinating, maintaining, and enhancing the company's GxP training program to support both clinical development and commercial operations. S/he will ensure that all employees, contractors, and relevant third parties are appropriately trained in accordance with regulatory requirements and will partner with functional leaders to design, deliver, and track effective training programs. S/he will report to the Associate Director, Quality Systems.
Responsibilities
Priovant is committed to developing therapies that address high unmet need in autoimmune disease. The QA Systems Manager will help advance this mission by coordinating, maintaining, and enhancing the company's GxP training program to support both clinical development and commercial operations. S/he will ensure that all employees, contractors, and relevant third parties are appropriately trained in accordance with regulatory requirements and will partner with functional leaders to design, deliver, and track effective training programs. S/he will report to the Associate Director, Quality Systems.
Responsibilities
- Administer the end-to-end GxP training lifecycle for clinical and commercial functions, including onboarding, role-based training, and refresher programs.
- Manage training assignments, user records, and track training completion.
- Develop, track and report training compliance metrics; identify gaps and recommend improvements to enhance program effectiveness.
- Ensure training programs comply with applicable GxP regulations.
- Coordinate with subject matter experts (SMEs) to develop and maintain training materials (e.g., SOPs, eLearning modules, job aids) that meet regulatory and operational requirements.
- Gather feedback from learners and managers to refine training content, delivery methods, training curricula, and overall program efficiency.
- Partner with other functions to support non-GxP training initiatives as required.
- Act as primary contact for the training program.
- Perform audits of training vendors.
- Lead and support ad hoc Quality Systems initiatives and operations as required, with a focus on inspection readiness.
- Bachelor's degree in one of the life sciences, computer science or equivalent knowledge and experience
- 5 years of experience in pharmaceutical industry, with experience in Quality Systems, Learning and Development, and/or Training Coordination
- Ability to adapt training content and delivery to diverse audiences
- Experience rolling out commercial training programs preferred
- Organized and thorough, with attention to details
- Hands-on, roll-up-your-sleeves approach, with a high sense of urgency and drive for results
- Demonstrated communication, problem-solving, and decision-making skills
- Natural collaborator who enjoys working on a cross-functional team