Senior Manager / 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