Associate Director/Director Quality Assurance
Legal | San Francisco, Ca | Full Time
The Parker Institute for Cancer Immunotherapy is an unprecedented collaboration between the country’s leading immunologists and cancer centers — Memorial Sloan Kettering Cancer Center, Stanford Medicine, the University of California, Los Angeles, the University of California, San Francisco, the University of Pennsylvania and The University of Texas MD Anderson Cancer Center — for the first time unifying the research programs, intellectual property licensing, data collection, and clinical trials across multiple centers under the umbrella of a single nonprofit biomedical research organization. The Parker Institute was created through a $250 million grant from The Parker Foundation.
The Parker Institute’s goal is to accelerate the development of breakthrough immune therapies capable of turning cancer into a curable disease by ensuring the coordination and collaboration of the field’s top researchers, and quickly turning their findings into patient treatments.
The Institute is based in San Francisco, California and was publicly announced in April 2016.
Key to the success of this effort will be the planning and implementation of clinical trials conducted at one or more member institutions as well as a network of sites external to the consortium, as appropriate.
Description of Duties
Reporting to the Chief Legal Counsel, VP of Strategic Alliances, the Associate Director/Director of Quality Assurance is responsible for developing and implementing strategy and policy relative to Clinical Quality Assurance, Clinical Quality Standards, and Vendor Management for Clinical Operations and ensuring excellence in compliance and the ability to satisfy internal and external scrutiny. The candidate will develop inspection strategies and process improvement plans related to Clinical Operations activities and will provide senior management with in-depth analysis and risk management on GCP QA related matters.
The Quality Assurance Associate Director/Director is responsible for the Quality Assurance aspects of clinical trials, ensuring trials conform to ICH-GCP, other applicable regulations and the relevant Standard Operating Procedures (SOPs). The Quality Assurance Associate Director/Director is independent of the Clinical Operations team. The Quality Assurance Associate Director/Director is responsible for preparing for and conducting audits and for reporting of audit findings, for trial specific, internal quality system, and vendor qualification audits.
Key responsibilities will include, but not necessarily be limited to, the following:
- Provide Quality leadership to the Clinical Operations team regarding Quality standards, regulations and regulatory guidance such as ICH GCP.
- Recommend and guide Quality Assurance activities including overseeing the support of GxP vendor audits, SOP review and updating and corrective action plans and documentation.
- Provide oversight and guidance to identify and determine compliance risks to internal teams including the Clinical Operations team, and to include incident reporting, corrective action plans, initiating and leading investigations. Provide risk mitigation input to identified risks.
- Direct the establishment and maintenance of compliant quality systems, processes and procedures in support of early phase clinical development. Is a trusted member of the PICI internal teams to advise on fit for purpose activities to ensure quality and compliance.
- Provide support to departments in finalizing or updating SOPs and associated guidance including document control management. Provide feedback to the team regarding training to ensure compliance with SOPs and policies.
- Support training via quality systems
- Support Quality Systems and Clinical Operations Auditing activities.
- Provide coaching, training and tools to the organization around regulatory inspections.
- Interpret global legislation, regulations and guidance for the Clinical Operations team to develop policies and standards, identify gaps and redundancies and coordinate and implement remediation plans in collaboration with Clinical Operations leadership, and other groups.
- Support the development of cross functional policies, standards, and processes to ensure teams are working effectively and collaboratively in compliance with global regulations and company standards.
- Assure compliance to the Clinical Operations SOPs and corporate standards impacting GCP/GLP/Pharmacovigilance activities by the implementation of compliance monitoring programs.
- Ensure the quality and integrity of data generated from the Parker Institute’s sponsored clinical investigations for submission to relevant regulatory agencies by overseeing the conduct of database, document, vendor and investigator site audits.
- Liaises with other functions such as Regulatory, Systems, Manufacturing and Research
University degree, preferably in a biologic/scientific discipline. Advanced degree is preferred.
- Experience in the pharmaceutical/biotech industry
- Participation and experience with a FDA inspection and audit
- At least 10 years of pharmaceutical industry/drug development experience
- At least 10 years global experience in Quality / Compliance with emphasis on GCP, GLP and PV
The appropriate candidate must:
- Act decisively
- Work collaboratively
- Exhibit passion for customers
- Drive performance
- Think strategically
- Help develop people and the PICI organization
- Possess outstanding operational experience and skills including the demonstrated ability to design quality and compliance goals and processes.