Senior Manager / Manager, Product Quality

Priovant Therapeutics is committed to developing therapies that address high unmet need in autoimmune disease. The Senior Manager / Manager, Product Quality will help advance this mission by ensuring complete and compliant documentation of CMC related activities for clinical and commercial operations, as well as developing Quality Systems across clinical development programs.

Responsibilities:

• Collaborate with CMC, Supply Chain, and Clinical Operations in the release of Clinical Trial Material (CTM) to support Priovant Therapeutics clinical development pipeline. This includes the disposition of material for global supply
• Collaborate with CMC to support any ongoing and new analytical needs (e.g. method validation/qualification/verification, stability, etc.) for clinical and commercial drug supply
• Collaborate with CMC to support product (e.g. DS, DP) and shipping validation as needed
• Serve as a backup for the release of commercial API, bulk DP, and packaged DP to support Proviant’s US commercial pipeline
• Support clinical and commercial documentation authoring and/or approval as needed
• Develop and implement procedures for the Priovant Therapeutics Quality Management System (QMS)
• Support internal, external, and regulatory audits as needed

Requirements:

• 6-12 years of experience in biopharmaceutical industry or related field with experience in GMP Quality
• Experience with US and global clinical studies across various stages of development (e.g. Phase I, II, and III)
• Experience with US commercial Quality, especially establishing systems for and managing DSCSA compliance
• Ability to audit a variety of operations independently
• Experience working with external vendors (e.g. CDMOs), including Qualified Persons (QP)
• 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
• Experience with oral solid dose Quality