Chinook Therapeutics Inc.
Chinook Therapeutics is a clinical-stage biotechnology company developing precision medicines for patients with kidney diseases. We apply our proprietary research platform to discover and develop therapeutics with novel mechanisms of action against key kidney disease pathways. Our development focus is on rare, serious disorders with clear unmet medical needs and defined and rapid clinical development opportunities. Our lead program, atrasentan, is a late-stage clinical program for the treatment of primary glomerular diseases, which is planned to move into a phase 3 registrational trial for IgA nephropathy and a phase 2 basket trial for glomerular diseases, both in early 2021. We are also evaluating BION-1301, an anti-APRIL monoclonal antibody, in a phase 1b trial for IgA nephropathy, and are advancing CHK-336 towards a planned IND in 2021 for an ultra-orphan kidney disease. In addition, our pipeline has several other preclinical programs at the validation and lead optimization stages, and we are also evaluating business development opportunities for early and late-stage clinical assets to enhance the pipeline.
Chinook launched in 2019 with a $65 million Series A financing from leading healthcare investors Versant Venture, Apple Tree Partners and Samsara Biocapital. In October 2020, we merged with Aduro Biotech, Inc. and completed a $115 million financing with leading healthcare investors, including EcoR1, Orbimed and others. Chinook now has over $275 million in operating capital and trades on Nasdaq under the ticker “KDNY”. The company has locations in Vancouver, BC, Seattle, WA and Berkeley, CA.
The Vice President of Quality Assurance is responsible for the strategic development and execution of the Company’s quality program, and is accountable for the execution and administration of the GXP Quality Systems to support GMP, GLP, and GCP compliance in accordance with ICH, US and EU regulations. The VP will build an internal team and relationships with external consultants/contractors, as necessary to support QA activities and responsibilities and provide leadership and guidance to the organization on global quality matters. This position requires expertise in current Good Manufacturing Processes (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP) and relevant regulations. The successful candidate will drive, promote and embed a culture of ethics, integrity and continuous improvement that will focus on delivering efficiencies.
Key Responsibilities Include:
- Ensures that the Quality System meets standards expected by US and global regulatory authorities for research, development and ultimately commercial activities.
- Ensures quality metrics comply with best industry standards and practices.
- Maintains an effective Quality governance and continually improve governance to meet business and compliance needs.
- Ensures overall Quality and Compliance oversight for manufacturing, supply chain, nonclinical and clinical. Determine applicable quality standards and regulations and provide guidance and quality oversight to ensure ongoing compliance.
- Establishes strong working relationships with external manufacturers of our products and assure alignment of our Quality Systems and requirements with these CDMOs. Ensures products manufactured at CDMOs meet company quality standards and government regulations.
- Establishes, maintains, and has oversight of internal Quality Management Systems. Continually establish and improve quality systems, initiatives, priorities, and timelines.
- Ensures appropriate quality criteria built into selection, implementation or upgrading of electronic systems used to support any GXP related activities
- Provides appropriate Quality oversight of external vendors (CMOs, CROs, etc.)
- Provides leadership and mentorship of the Quality team. Plans and oversees day-to-day activities of the Quality function including management of consultants/auditors as needed to ensure project and business needs are met.
- Keeps abreast of industry developments, forthcoming regulations, guidance, best practices etc.
- Counsels, train and interpret quality requirements to ensure we and our GxP vendors maintain a state of compliance.
- Communicates significant quality risks that may impact product suitability or regulatory compliance in a timely manner to Executive Management.
- Serve as an escalation point for corporate quality issues.
- Serves as primary contact in any audit by a regulatory authority and lead all audit communications with audit personnel from a regulatory agency. Responsible for supplier/vendor qualification audit and inspection management.
- Conducts all duties in compliance with country specific regulations, applicable SOPs, and other applicable guidelines
- 15+ years of pharmaceutical industry experience
- Advanced Degree in scientific discipline required
- Proficient experience managing Quality Systems/SOPs
- Experienced in establishing quality organization and developing staff
- Exceptional organizational skills with the ability to prioritize deadlines, maintain focus and monitor progress on assigned tasks
- A creative, collaborative approach to problem solving
- Excellent written and verbal communication and presentation skills
- Occasional travel is required to perform vendor audits and oversee GMP manufacturing
- Extensive experience in GXP environment and in-depth knowledge of pharmaceutical GMP
Please use the following link to apply: https://chinooktx.bamboohr.com/jobs/view.php?id=95
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.