Senior Associate​/Manager, Quality

Priovant is committed to developing therapies that address high unmet need in autoimmune disease. The Associate / Manager, Quality will help advance this mission by ensuring complete and compliant documentation of clinical study activities. S/he will also assist in developing Quality Systems and executing within these systems across Priovant's clinical development programs. S/he will report to the Director, Quality.

• Track, upload, and manage documentation required to be in the TMF across studies. This includes working with internal and external collaborators to obtain documentation, respond to queries, and track TMF health.
• Collaborate with other quality and clinical operations staff on study oversight metric input and review. Additionally, create action plans for metrics that exceed KPIs.
• Use metrics to identify clinical study sites with higher than desired clinical risk and work to mitigate these risks.
• Perform clinical site, TMF, and/or vendor site audits, as needed.
• Support clinical site inspection readiness.
• Develop and implement procedures for the Priovant Therapeutics Quality Management System (QMS).

• Bachelor's degree in one of the life sciences, or equivalent knowledge and experience
• 6-12 years of experience in biopharmaceutical industry or related field with experience in GCP Quality, experience in additional GXP disciplines a plus
• 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