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General Information

Job Name
Product Compliance Specialist
Department
1210880 - M NeuSrg ZSFG
Position type
Full Time
Workplace
Fully Off-Site
Primary Location
United States
Job ID
2354

Description & Requirements

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 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 https://www.ucsf.edu/about/mission-and-values . In addition to , 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 https://diversity.ucsf.edu/ . Join us to find a rewarding career contributing to improving healthcare worldwide.
EEO Statement
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.

Additional Details

Job Code
RSCH CMPLNC ANL 4 (006231)
Assignment Category
Career
IAP Level
None
Job Family
Research Administration
Campus 1
Zuckerberg San Francisco General (ZSFG)
Percentage (%)
100
Shift Length
8 hours
Shift Type
Day
Bargaining Unit
99
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