Senior Director, Quality Assurance (GC011)
Tricida, Inc. is a privately-held, clinical stage, biopharmaceutical company focused on the discovery and development of non-absorbed therapies. Tricida’s lead investigational drug candidate, TRC101, represents a first-in-class approach to the treatment of metabolic acidosis, a common complication of chronic kidney disease (CKD) that can result in increased mortality, accelerated progression of kidney disease, progressive muscle breakdown and exacerbation of bone disease. Tricida is led by a management team with an accomplished and proven track record in discovering and developing new therapeutics, with extensive experience in building successful companies around strong science and unmet medical needs. The Company is backed by world-class venture capital firms. We are expanding our existing group of exceptionally talented and motivated professionals.
As Senior Director, Quality Assurance, you will be responsible for providing current Good Manufacturing Practice (cGMP) quality oversight to drug substance and drug product manufacturing activities at Contract Service Providers. This leadership role entails managing Tricida’s quality assurance systems and activities to assure compliance with applicable regulatory standards during late stage development activities, preparation for an NDA submission and future commercialization for its polymer drug for the treatment of metabolic acidosis.
- Provide quality oversight to manufacturing activities at drug substance and drug product contract service providers (CSP).
- Lead resolution of quality issues with CSPs and internal teams in a timely manner.
- Manage activities related to disposition of clinical and commercial product.
- Manage the CSP qualification and performance monitoring program.
- Conduct CSP and Tricida internal audits; manage and monitor the effectiveness of any resulting corrective/preventative actions.
- Lead Tricida’s risk assessment team(s) to identify, evaluate and mitigate/eliminate quality and compliance risks.
- Lead the transition of Tricida’s Quality System to an Electronic Quality Management System.
- Lead the preparation, negotiation and implementation of Quality Agreements with applicable CSPs.
- Lead cGMP regulatory pre-approval inspection and routine inspection activities (preparation, conduct, and responses) at Tricida.
- Assist CSPs with preparation for cGMP pre-approval inspections and routine inspection activities.
- Manage Tricida’s product quality complaint system to ensure timely review, investigation, tracking, trending and closure.
- Establish Tricida’s system to track, trend and report quality metrics.
- Provide periodic quality management system reviews to Tricida senior management.
Experience and Skills:
- Minimum Bachelor’s degree in a scientific discipline, with a minimum of 10 years in QA with increasing QA leadership roles and responsibilities.
- In-depth knowledge and full understanding of cGMP requirements (US and EU) for drugs in late-stage development and commercial stage.
- Solid understanding of standards of practice for the manufacture of solid dosage form drugs.
- Prior experience with implementing and/or maintaining electronic quality systems in a cGMP environment.
- Experience with establishing validated documentation systems and a strong understanding of 21CFR Part 11 requirements.
- Ability to critically evaluate and troubleshoot complex problems, while offering timely and informed options for resolution.
- Must have excellent verbal and written communication skills, as well as excellent organizational skills.
- Excellent leadership and interpersonal skills are a must to effectively interact with and influence different functional groups at all levels of management.
- Position may require travel (up to 10%).
Competitive Compensation and Benefits include: Medical, Dental, and Vision Coverages, Life, AD&D, Disability, 401(k), Flexible Spending Plan, and Pre-IPO stock. 15 vacation days per year and 11 paid holidays per year, which includes 1 floating holiday.
Tricida is located in South San Francisco, CA.
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