Product Compliance Specialist

Job Function Summary:

Involves staffing, administering or managing research oversight and compliance committee activities related to research activities such as human subjects, animal use and care, conflict of interest and export control. Reviews research protocols for use in specific fields, assists in writing and reviewing protocols, and compliance with federal, state, and University mandated laws, regulations and policies.

Generic Scope

Technical leader with a high degree of knowledge in the overall field and recognized expertise in specific areas; problem-solving frequently requires analysis of unique issues / problems without precedent and / or structure. May manage programs that include formulating strategies and administering policies, processes, and resources; functions with a high degree of autonomy.

Custom Scope

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.

Lead and coordinate cross-functional teams to ensure the CMO’s seamless product development

Expanded Responsibilities:

• Serve as the primary CMC lead interfacing with the CMO’s internal functional groups (Manufacturing, MSAT, Quality, Regulatory Affairs, Supply Chain, Analytical Development, Validation) and external partners/sponsors.

• Drive alignment across technical teams to ensure process development, scale-up, validation, and commercial readiness milestones are met.

• Identify cross-functional risks and proactively implement mitigation strategies.

• Ensure clear communication of technical updates, risks, and key decisions to senior leadership and external stakeholders.

• Promote adherence to cGMP standards and company quality systems across all functional areas

Manage the CMO’s project timelines and budgets related to CMC activities. 

Expanded Responsibilities:

• Develop and maintain detailed CMC project timelines spanning development, validation, regulatory submission, and lifecycle management phases.

• Track progress against key milestones including:

• Process development

  • Method development and validation

  • Engineering and process validation batches

  • Stability studies

  • Regulatory submission deadlines

• Monitor and manage CMC budgets, including:

  • Manufacturing campaign costs

  • Analytical testing costs

  • Validation expenses

  • External vendor/CMO services

Oversight of the CMO’s deliverables related to ensure all aspects of manufacturing, testing, and analytical development meet stringent regulatory requirements. 

Expanded Responsibilities:

• Ensure all CMC activities comply with global regulatory standards including FDA, EMA, ICH, and other applicable authorities.

• Oversee:

  • Process development and scale-up activities

  • Analytical method development, qualification, and validation

  • Process validation and continued process verification

  • Stability program design and monitoring

• Review and approve key technical documentation including:

  • Batch records

  • Validation protocols and reports

  • Analytical methods and specifications

  • Change controls and deviation investigations

• Ensure manufacturing processes adhere to cGMP requirements and data integrity standards.

Initiates and designs the development and revision of operating procedures, policies,Oversight of the CMO’s deliverables related to develop and submit CMC sections of regulatory dossiers to agencies like the FDA and EMA. 

Expanded Responsibilities:

• Lead the preparation, review, and finalization of CMC sections for regulatory submissions, such as INDs

• Coordinate compilation of manufacturing, analytical, validation, and stability data for submission.

• Ensure consistency between Quality Overall Summary (QOS) and detailed technical sections.

• Collaborate with Regulatory Affairs to address agency queries, deficiency letters, and information requests.

• Support preparation of responses to FDA/EMA questions within required timelines.

• Ensure lifecycle management updates (e.g., process changes, site changes, specification updates) are accurately reflected in post-approval submissions.

• Maintain regulatory intelligence awareness to anticipate evolving CMC requirements.

Required Qualifications

• Bachelor’s degree in related areas
• 5 years of related experience 
• Demonstrated self-discipline and independent judgment completing highly complex, broadly defined assignments
• Advanced knowledge and ability to apply all relevant Federal, state, and university regulations policies, and federal guidance documents
• Advanced knowledge of quantitative and qualitative research design, scientific research concepts and terminology
• Strong scientific knowledge in areas like analytical development and process development
• Excellent project management skills, including planning, execution, and risk management 
• Proficiency in communicating complex scientific data to technical and non-technical audiences
• Deep understanding of regulatory requirements and GMP principles
• Strong proficiency in public speaking, and writing

Preferred Qualifications

• Master's degree or PhD in related area and / or equivalent experience and training.
• Relevant compliance certification (if applicable) preferred.