Product Compliance Specialist
About The Position
The Product Compliance Professional will represent the Regulatory Sponsor (UCSF) and provide strategic oversight of contract manufacturing organizations (CMOs) supporting a complex, double-blinded, randomized, multi-site adaptive platform trial evaluating multiple investigational agents in parallel. This role serves as the lead for cGMP compliance, Quality Assurance (QA), and Chemistry, Manufacturing, and Controls (CMC) regulatory oversight on behalf of UCSF. The position is responsible for comprehensive review and oversight of all CMO deliverables to ensure compliance with contractual Statements of Work and applicable regulatory standards, as well as coordination of clinical supply production across multiple manufacturing campaigns. The individual will oversee investigational product forecasting and supply planning, manage technical risk, interpret and resolve manufacturing and quality issues, and provide strategic recommendations prior to submission of materials to the study funder, the U.S. Department of Defense. The role requires ongoing cross-functional engagement with CMO manufacturing and IRT teams, the Regulatory Sponsor, and federal stakeholders to ensure alignment, quality, and timely execution.
Requirements
- High degree of knowledge in the overall field.
- Recognized expertise in specific areas.
- Ability to solve unique issues/problems without precedent and/or structure.
- Experience managing programs that include formulating strategies and administering policies, processes, and resources.
- High degree of autonomy.
- Experience with cGMP compliance.
- Experience with Quality Assurance (QA).
- Experience with Chemistry, Manufacturing, and Controls (CMC) regulatory oversight.
- Experience reviewing and overseeing CMO deliverables.
- Experience ensuring compliance with contractual Statements of Work and applicable regulatory standards.
- Experience coordinating clinical supply production.
- Experience overseeing investigational product forecasting and supply planning.
- Experience managing technical risk.
- Experience interpreting and resolving manufacturing and quality issues.
- Experience providing strategic recommendations.
- Experience with cross-functional engagement with manufacturing teams, IRT teams, regulatory sponsors, and federal stakeholders.
Nice To Haves
- Experience with complex, double-blinded, randomized, multi-site adaptive platform trials.
- Experience evaluating multiple investigational agents in parallel.
- Experience working with the U.S. Department of Defense.
Responsibilities
- Provide strategic oversight of contract manufacturing organizations (CMOs).
- Serve as the lead for cGMP compliance, Quality Assurance (QA), and Chemistry, Manufacturing, and Controls (CMC) regulatory oversight.
- Conduct comprehensive review and oversight of all CMO deliverables.
- Ensure compliance with contractual Statements of Work and applicable regulatory standards.
- Coordinate clinical supply production across multiple manufacturing campaigns.
- Oversee investigational product forecasting and supply planning.
- Manage technical risk.
- Interpret and resolve manufacturing and quality issues.
- Provide strategic recommendations prior to submission of materials to the study funder.
- Engage cross-functionally with CMO manufacturing and IRT teams, the Regulatory Sponsor, and federal stakeholders.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
