Tricida, Inc. is an innovative development stage biopharmaceutical company, founded in 2013. We have recently closed Series C financing of $55M, thus raising $95M to complete our development program. We are focused on the discovery and development of first-in-class therapeutics for metabolic, renal and cardiovascular 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.
Reporting to the Sr. Director of QC/QA, you will partner with her in maintaining Quality Systems and assisting in compliance with applicable FDA and international standards, regulations and guidelines.
• Maintain internal GMP Quality Systems processes and procedures; manage and ensure proper training for GMP processes across multiple departments.
• Support management of external contract service providers (CSP) and assure their compliance with applicable standards, regulations and guidelines.
• Assist in directing Quality Assurance (QA) programs and activities, including training and auditing programs within the company.
• Work directly with operating entities (internal and external CSPs) to ensure that drug substance and drug product meet required quality standards and specifications.
• Identify compliance risks based upon audits and current regulations; evaluate corrective action plans and ensure appropriate steps are taken to address the corrective action plan.
• Manage release and disposition of drug substance and drug product.
• Provide effective QA support for CMC and nonclinical testing.
• Maintain the CSP audit schedule; conduct CSP audits (or coordinate the performance if using external consultants) and lead the preparation of resulting audit reports and close-out of CSP audit findings.
• Assist in the preparation and review of Quality Agreements with CSPs.
• Facilitate resolution of quality issues with internal and external parties in a timely manner. Coordinate communications with CSPs and internal team for quality issues and guide effective resolution of deficiencies.
• Establish metrics to evaluate the effectiveness of Quality Systems.
• Review sections of regulatory filings, as requested.
• Bachelor’s degree in a scientific discipline, or comparable experience. Minimum of 5 years of hands on experience with increasing responsibility in a QA function. Prior demonstrated managerial/leadership experience is a plus.
• Hands-on GMP experience with all phases of drug development as well as in-depth knowledge and full understanding of GMP requirements (US and EU).
• Solid understanding of standards of practice for the manufacture of solid dosage form drugs is a plus.
• Hands-on experience with implementing and/or maintaining quality systems in a GMP environment with prior experience performing supplier audits.
• Demonstrated ability to manage tasks (direct and indirectly) and variable workloads with demanding timelines.
• Ability to critically evaluate and troubleshoot complex problems, while offering timely and informed options for resolution.
• Must have excellent verbal and written skills, including strong organizational and management skills.
• Excellent interpersonal skills with the ability to effectively interact with and influence different functional groups at all levels of management.
• Experience with establishing validated documentation systems and a strong understanding of 21CFR Part 11 requirements a plus.
• Position may require travel.
Competitive Compensation and Benefits include: Medical, Dental, and Vision Coverages, Life, AD&D, Disability, 401(k), Flexible Spending Plan, and Pre-IPO stock options. 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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