Manager/Senior Manager, Clinical Quality

Priovant is committed to developing therapies that address high unmet need in autoimmune disease. The Manager / Senior Manager, Clinical 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. Responsibilities Serve as the primary Clinical QA point of contact for a Phase 3, global study Collaborate with cross-functional groups to support study start up and execution Collaborate with other quality and clinical operations staff on study oversight metric input and review. Create action plans for metrics. Use metrics to identify clinical study sites with higher than desired clinical risk and work to mitigate these risks. Review monitoring reports, primarily focused on outsourced monitoring activities, to identify and mitigate risks. In collaboration with Clinical Operations, resolve protocol deviations and open action items. Perform clinical site audits, as needed. Support clinical site inspection readiness. Develop and implement procedures for the Priovant Therapeutics Quality Management System (QMS) Qualifications 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 Ability to audit a variety of operations independently 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