Director, Clinical Quality Assurance
Rigel Pharmaceuticals, Inc. is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with immune and hematological disorders, cancer and rare diseases. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company's current clinical programs include clinical trials of fostamatinib, an oral spleen tyrosine kinase (SYK) inhibitor, in a number of indications. Rigel has submitted an NDA to the FDA for fostamatinib in patients with chronic or persistent immune thrombocytopenia (ITP). In addition, Rigel has product candidates in development with partners BerGenBio AS, Daiichi Sankyo and Aclaris Therapeutics.
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 FDA inspections and will be a primary contact during the inspection.
KNOWLEDGE AND SKILL REQUIREMENTS:
The ideal candidate will have a minimum of a Bachelor’s degree and preferably an applicable advanced degree with at least ten years of experience in clinical research quality assurance (all aspects), with additional experience in systems QA with a deep understanding of flexible and value-added QA processes and implementations thereof. Drug development lifecycle experience is highly desired. Qualified candidate should possess a strong knowledge of Good Clinical Practices (FDA and ICH), a good understanding of 21CFR Part 11 with respect to clinical processes and systems, including database and eCRF validation procedures, eCTD Quality Assurance, and the ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible and constructive manner. Some GLP (Good Laboratory Practices) experience is also desirable. Attention to detail as well as a crisp, clear and concise style in written and oral communications is required.
- Broad knowledge of risk-based quality systems approaches consistent with ICH E-6 for Good Clinical Practice.
- Requires solid experience with all phases of clinical studies.
- Experience leading inspection-readiness activities resulting in successful FDA inspection is required.
- Excellent written/oral communications skills, presentation skills and attention to detail.
- Demonstrated ability to work independently, flexibility and the ability to manage variable workloads.
- Ability to travel both domestic and internationally, if needed.
Rigel Pharmaceuticals Inc. is an Equal Opportunity Employer with a commitment to diversity.
All individuals are encouraged to apply.