Director, Clinical Quality Assurance
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POST DATE 9/14/2016
END DATE 11/15/2016
Rigel Pharmaceuticals, Inc.
South San Francisco, CA
JOB DESCRIPTIONPOSITION SUMMARY:
As a leader in Clinical QA, this individual is responsible for serving as a strategic and tactical quality resource in managing quality and regulatory compliance related to GCPs, pharmacovigilance and other related activities. The incumbent will provide support and promote collaboration internally to ensure all systems, processes, and their outcomes comply with applicable international and national standards, regulations, and guidelines. The incumbent will also provide leadership through contributions to strategic planning, development, implementation, and management of Clinical Quality Assurance and Data Sharing/Disclosure operational processes, systems, tools, and best practices.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
The position is responsible for such systems within CQA and all cross-functional organizations involved in clinical research activities in collaboration with matrix and CRO/vendor partners, as appropriate. This individual actively leverages audit/inspection outcomes/trends to effect sustained improvement in clinical trial conduct and reporting while championing the highest standards of compliance in Rigel clinical trials and with Rigel and global regulatory requirements in support of CQA and Corporate objectives. In conjunction with the Director QA (GMP), this position will lead the effort in preparation for our first FDA inspection and will be the primary contact during the inspection.
Additional responsibilities assigned as needed.