Product Compliance Specialist

University of California, San Francisco; San Francisco (CA); On-site; USD 150,000 - 200,000; Full time

Job summary

University of California, San Francisco (UCSF) in San Francisco seeks a Product Compliance Professional to provide strategic oversight of contract manufacturing organizations (CMOs) supporting a complex, multi-site adaptive platform trial. You will lead cGMP compliance, QA, and CMC regulatory oversight on behalf of UCSF.

The role requires coordinating review of CMO deliverables, ensuring regulatory and contractual standards, and guiding risk management and resolution of manufacturing and quality

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.

Skills

5 years of related experience

Regulatory GMP

Project management

Scientific data communication

Public speaking

Written communication

Education

Bachelor’s degree in related areas

Master's degree or PhD in related area

Job description

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.

Job Description

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.

Qualifications

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.

About Us

About UCSF

The University of California, San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. It is the only campus in the 10-campus UC system dedicated exclusively to the health sciences. We bring together the world’s leading experts in nearly every area of health. We are home to five Nobel laureates who have advanced the understanding of cancer, neurodegenerative diseases, aging and stem cells.

Pride Values

UCSF is a diverse community made of people with many skills and talents. We seek candidates whose work experience or community service has prepared them to contribute to our commitment to professionalism, respect, integrity, diversity and excellence – also known as our PRIDE values .

In addition to our PRIDE values, UCSF is committed to equity – both in how we deliver care as well as our workforce. We are committed to building a broadly diverse community, nurturing a culture that is welcoming and supportive, and engaging diverse ideas for the provision of culturally competent education, discovery, and patient care. Additional information about UCSF is available here .

Join us to find a rewarding career contributing to improving healthcare worldwide.

Equal Employment Opportunity

The University of California is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected status under state or federal law.

Salary Information

The final salary and offer components are subject to additional approvals based on UC policy.

Your placement within the salary range is dependent on a number of factors including your work experience and internal equity within this position classification at UCSF. For positions that are represented by a labor union, placement within the salary range will be guided by the rules in the collective bargaining agreement.

To learn more about the benefits of working at UCSF, including total compensation, please visit: https://ucnet.universityofcalifornia.edu/compensation-and-benefits/index.html