SR. MANAGER/ASSOCIATE DIRECTOR, QUALITY ASSURANCE
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POST DATE 9/10/2016
END DATE 10/10/2016
South San Francisco, CA
JOB DESCRIPTIONAPPLY 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.
You will partner with the Sr. Director of QC/QA in maintaining Quality Systems and assist 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.