Product Compliance Specialist
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UCSF
San Francisco, CA, US
Summary
Provide strategic oversight of contract manufacturing organizations to ensure cGMP, QA, and CMC compliance for a complex clinical trial. Manage investigational product forecasting, supply planning, and technical risk while coordinating with federal stakeholders and the Department of Defense.
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.
Responsibilities
| % of time | Essential Function (Yes/No) | Key Responsibilities (To be completed by Supervisor) |
|---|---|---|
| 25% | Yes |
Lead and coordinate cross-functional teams to ensure the CMO’s seamless product development Expanded Responsibilities:
|
| 25% | Yes |
Manage the CMO’s project timelines and budgets related to CMC activities. Expanded Responsibilities:
|
| 25% | Yes |
Oversight of the CMO’s deliverables related to ensure all aspects of manufacturing, testing, and analytical development meet stringent regulatory requirements. Expanded Responsibilities:
|
| 25% | Yes |
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:
|
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 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
The Department of Anesthesia and Perioperative Care at UC San Francisco is a pioneering leader in providing outstanding, state of the art healthcare that is equitable and inclusive. In alignment with the wider UCSF mission to advance health worldwide, we are committed to optimizing perioperative outcomes, training the next generation of anesthesiology leaders, and translating discoveries to benefit the health and life of our patients and the wide range of communities we serve.
Consistently ranked in the top ten nationally in NIH-funded research, important discoveries by our department include the first use of CPAP in premature infants, key contributions to the pharmacology of muscle relaxants and inhaled anesthetics, first demonstration of intraoperative transesophageal echocardiography, and many others [https://anesthesia.ucsf.edu/anesthesia-timeline-fullscreen]. We have robust research programs, spanning the range from ion channel structure and function, to clinical and translational research [https://anesthesia.ucsf.edu/welcome-ucsf-anesthesia-research].
Our trainees have become leaders across the country. We are particularly proud of our residency program [https://anesthesia.ucsf.edu/education-program-ucsf-department-anesthesia], which provides unequaled diversity of experience in a major university medical center (UCSF Helen Diller Medical Center at Parnassus Heights), the San Francisco Veterans Hospital, Zuckerberg San Francisco General Hospital, Mount Zion Hospital, the UCSF Orthopaedic Institute, and the UCSF Benioff Children's, Betty Irene Moore Women's and Bakar Cancer (NIH-designated Cancer Center) Hospitals in the Mission Bay neighborhood. We offer ACGME fellowships in Critical Care Medicine, Pain Medicine, Cardiac Anesthesia, Obstetric Anesthesia, Pediatric Anesthesia, Acute Pain and Regional Anesthesia, and many additional non-ACGME fellowships. Our faculty are dedicated to teaching, nurturing, and mentoring the next generation of leaders.
Founded
1958
Company size
501-1,000 employees
Industry
Hospitals and Health Care
Org type
Educational
Headquarters
San Francisco, CA
The Department of Anesthesia and Perioperative Care at UC San Francisco is a pioneering leader in providing outstanding, state of the art healthcare that is equitable and inclusive. In alignment with the wider UCSF mission to advance health worldwide, we are committed to optimizing perioperative outcomes, training the next generation of anesthesiology leaders, and translating discoveries to benefit the health and life of our patients and the wide range of communities we serve.
Consistently ranked in the top ten nationally in NIH-funded research, important discoveries by our department include the first use of CPAP in premature infants, key contributions to the pharmacology of muscle relaxants and inhaled anesthetics, first demonstration of intraoperative transesophageal echocardiography, and many others [https://anesthesia.ucsf.edu/anesthesia-timeline-fullscreen]. We have robust research programs, spanning the range from ion channel structure and function, to clinical and translational research [https://anesthesia.ucsf.edu/welcome-ucsf-anesthesia-research].
Our trainees have become leaders across the country. We are particularly proud of our residency program [https://anesthesia.ucsf.edu/education-program-ucsf-department-anesthesia], which provides unequaled diversity of experience in a major university medical center (UCSF Helen Diller Medical Center at Parnassus Heights), the San Francisco Veterans Hospital, Zuckerberg San Francisco General Hospital, Mount Zion Hospital, the UCSF Orthopaedic Institute, and the UCSF Benioff Children's, Betty Irene Moore Women's and Bakar Cancer (NIH-designated Cancer Center) Hospitals in the Mission Bay neighborhood. We offer ACGME fellowships in Critical Care Medicine, Pain Medicine, Cardiac Anesthesia, Obstetric Anesthesia, Pediatric Anesthesia, Acute Pain and Regional Anesthesia, and many additional non-ACGME fellowships. Our faculty are dedicated to teaching, nurturing, and mentoring the next generation of leaders.
Founded
1958
Company size
501-1,000 employees
Industry
Hospitals and Health Care
Org type
Educational
Headquarters
San Francisco, CA
