Chinook Therapeutics is a clinical-stage biotechnology company developing precision medicines for kidney diseases. Chinook’s product candidates are being investigated in rare, severe chronic kidney disorders with opportunities for well-defined clinical pathways. Chinook’s lead program is atrasentan, a phase 3 endothelin receptor antagonist for the treatment of IgA nephropathy and other proteinuric glomerular diseases. BION-1301, an anti-APRIL monoclonal antibody is being evaluated in a phase 1/2 trial for IgA nephropathy. In addition, Chinook is advancing CHK-336, an oral small molecule LDHA inhibitor for the treatment of primary hyperoxaluria, as well as research programs for other rare, severe chronic kidney diseases.
Chinook is building its pipeline by leveraging insights in kidney single cell RNA sequencing, human-derived organoids, and new translational models, to discover and develop therapeutics with differentiating mechanisms of action against key kidney disease pathways. Chinook trades on Nasdaq under the ticker symbol KDNY and has locations in Vancouver, BC, Seattle, WA and Oakland, CA.
The Sr. Director, Quality Compliance position requires a strong leader as part of the Quality team to lead Chinook’s GMP Quality Compliance function. The Sr. Director of Quality Compliance will serve as a strategic and tactical quality professional in managing GMP compliance related to contract organizations and internal processes encompassing Good Distribution Practices (GDP’s) and Good Manufacturing Practices (GMP’s). This position plays a significant role in support of the vendor management program and other related activities including, but not limited to, regulatory surveillance, inspection readiness, inspection management, internal audit, external audit, and due diligence. The Sr. Director of GMP Quality Compliance is responsible for ensuring oversight of compliance with FDA, EMA, Health Canada, PMDA, regulations and ICH guidelines applicable to GDP and GMPs, including medical devices, best practices, and internal policies and procedures. The Sr. Director of GMP Quality Compliance will be responsible for surveillance of industry trends and changing regulations and will provide ownership and oversight of continuous improvement of GMP compliance processes. The position will partner with the CMC & Technical Operations departments (Process Development, Manufacturing, Supply Chain) to provide strategic GDP and GMP compliance oversight for all Chinook programs and internal operations. The Sr. Director of Quality Compliance will preferably be based in one of the Chinook West coast offices (Vancouver, BC; Seattle, Washington; Berkeley, CA; San Diego, CA) or may be remote and will report to the Vice President of Quality.
- Lead Chinook’s GMP Compliance function while promoting a culture of quality by collaborating across all departments and levels of management to accomplish company objectives.
- Lead the GMP inspection management program, including pre-approval inspection readiness of vendors and suppliers, internal inspection readiness activities, inspection conduct, and preparation of responses to health authorities.
- Lead the GMP external audit program including development, maintenance and execution of the annual GMP external audit plan. Partner externally to perform effective audits of GMP vendors (contract manufacturing (CMO), laboratory (CTL), distribution and computer service organizations), and ensure responses are tracked and effectively completed.
- Lead the GMP internal audit program and collaborate internally to execute routine, risk-based monitoring and auditing of relevant internal GMP business activities to applicable regulations, guidelines, policies and procedures; identify potential areas of compliance vulnerability and risk; oversee the implementation of corrective action plans as necessary; and generate reports on monitoring, auditing and risk assessment for the business.
- Ensure all audit observations are communicated, tracked and remediated in compliance with internal policies as well as with all applicable regulatory requirements.
- Facilitate the Chinook biological product deviation reporting, field alerts, medical device reporting, recall, or product withdrawal processes and associated committees.
- Ensure annual GMP training of internal company employees.
- Drive continuous improvement efforts and support the development and implementation of the Quality Plan to ensure Chinook quality objectives are met.
- Assess new and emerging regulations and inspection trends for impact to GMP activities and apply changes in a fit for purpose manner to Chinook’s Quality Management System and practices.
- As required, provide performance reviews, development plans and set goals for department staff in alignment with company goals.
- Contribute to the development and maintenance of a positive team-focused company culture.
- This position requires travel up to 25%.
Education, Experience, and Skills:
- BS or BA degree or equivalent in a science or health care field and significant experience in an FDA-regulated environment.
- Minimum of 12 years of experience in the pharmaceutical industry with a GMP focus, ideally covering several areas supporting commercial manufacturing operations, with five (5) years in a GMP quality role.
- Demonstrated competence in direct participation in health authority inspections is required. Broad knowledge of GMP processes and procedures, electronic systems that support manufacturing operations, and GDP and GMP regulations and guidance with demonstrated effectiveness in maintaining audit programs.
- Experience conducting quality audits of CMO, CTL, distributors, and computer system providers.
- Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors in all dealings is essential and required.
- Experience with Phase 3 and/or commercial biologic drug substance manufacturing.
- An advanced degree in sciences or business.
- In-depth knowledge and understanding of medical device requirements including the application EU medical device directives and ISO 13485
- In-depth knowledge and understanding of Japanese (JPMDA), Canadian (Health Canada, PIC/S, and WHO GMP requirements
- Prefer candidate understand standards of practice for the manufacture of small molecule and biologic drug substances and drug products in both parenteral and solid dosage forms.
- Experience with effectively managing FDA inspection, working with regulators, and supplier audits.
Chinook is an Equal Opportunity Employer, and we prohibit discrimination or harassment of any kind. We are committed to fostering an environment where ALL people are welcome and supported. We respect and value different experiences and viewpoints. We act respectfully toward one another and embrace diversity of people and ideas. Having a diverse workforce made up of team members who bring a wide variety of skills, abilities, experiences, and perspectives is essential to our success. Creativity and innovation flourish in an environment of openness, inclusion, and mutual respect.