Chinook Therapeutics Job Description:
Sr. Director, Quality Assurance
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 1b 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 Assurance (QA) is responsible for providing leadership, direction, and Quality Assurance oversight of contract manufacturers (CMOs) and service providers for all drug substance (DS), drug product (DP), packaging and labeling, and distribution of investigational and marketed drug products. This person collaborates with Quality Compliance, Quality Control, and Quality Management Systems staff to ensure compliance with all relevant cGMP regulations and guidelines as they pertain to manufacturing, packaging and labeling, and supply activities. The Sr. Director, Quality Assurance provides QA expertise and guidance in supporting the development and product quality strategy for CMC teams and is responsible for day-to-day quality oversight activities of CMO manufacturing, including but not limited to, disposition of all materials, deviation resolution, CAPA, changes, and documentation supporting the suitability of batches. The Sr. Director is responsible for ensuring QA staff execute the company’s Quality Management System and adhere to policies and procedures. The Sr. Director of Quality Assurance will preferably be based in one of the Chinook West coast offices (Vancouver, BC; Seattle, Washington; Berkeley, CA; San Diego, CA) and will report to the Vice President of Quality.
- Provide QA support for the manufacturing and disposition of Chinook GMP starting materials, DS (API), DP, and packaged and labeled products. Responsible for disposition of GMP products utilizing trained and qualified QA staff. In addition, collaborate with Manufacturing, Supply Chain and Program Management to assure on time delivery of approved products.
- Work directly with operating entities (internal and CMOs) to ensure that Chinook products (i.e., DS (API), DP, and packaged and labeled product) meet all required quality standards and specifications.
- Build and provide leadership for the Quality Assurance team.
- Represent the Quality function in product development (CMC) teams, engaging all quality stakeholders to ensure product deliverables are met through the product lifecycle.
- Influence other functional departments to ensure that CMOs achieve and maintain the appropriate levels of GMP compliance and provide quality services to Chinook. In addition, work with CMOs to ensure CMOs’ cGMP processes and procedures provide continuous evaluations and improvements to their quality systems.
- Responsible for executing Quality Assurance (QA) programs and activities; this includes assisting with training and auditing programs, as well as the review of SOPs, investigations, specifications, methods, reports and manufacturing records.
- Assist the Chinook Quality Management Systems (QMS) team in the development, establishment and maintenance of internal Quality Systems processes and procedures (e.g., change control, training, audit, CMO management, deviation and CAPA) that complies with applicable GMP standards, regulations and guidelines.
- Assist the Quality Compliance team to conduct CMO audits as an SME or lead auditor.
- Provide QA guidance and support for supplier qualification, technology transfer, scale-up, validation and other GMP activities associated with Chinook products manufactured by CMOs.
- Facilitate resolution of quality issues with internal and external parties in a timely manner. Coordinate communications with CMOs and internal technical product teams for quality issues.
- Review and approve CMC sections of regulatory filings as needed.
- Contribute to the development and maintenance of a positive team-focused company culture
Education, Experience, and Skills:
- BA or BS degree in a scientific discipline or comparable experience.
- At least 15 years of experience in Quality Assurance at an operational level supporting manufacturing and quality control in a pharmaceutical or biotech environment.
- In-depth knowledge and full understanding of pharmaceutical cGMPs, with expertise in FDA and EMA regulations and applicable guidance at a minimum.
- Must have excellent verbal, written, interpersonal, and organizational and communication skills.
- Demonstrate ability to manage staff and projects (direct and indirectly) and variable workloads with demanding timelines.
- Position requires 10-20% travel.
- Minimum of 2 years in outsourced manufacturing environment.
- Experience with Phase 3 and/or commercial biologic drug substance manufacturing.
- An advanced degree in sciences or business.
- Recent experience in preparation of CMC sections of US or EU regulatory approval (e.g., BLAs, NDAs) is desirable.
- Prior experience related to managing technology transfer, scale up and validation.
- 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 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.