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