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Director of Quality Assurance - Bala Cynwyd

Company: Chondrial Therapeutics, Inc.
Location: Bala Cynwyd
Posted on: July 16, 2019

Job Description:

US-PA-Bala CynwydID 2019-1151# of Openings 1OverviewThe role, Director of Quality Assurance, is intended to implement and lead Quality Systems supporting GxP activities, including Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), Good Clinical Practices (GCP) and Good Laboratory Practices (GLP) for a virtual company in which contract service providers are used for manufacturing, laboratory testing, clinical studies, etc. This is an exciting opportunity to get involved with a cutting-edge company developing drugs to treat rare mitochondrial diseases. Summary of Position:This position is critical to the successful assurance of quality product manufacturing, clinical data collection, and the proper functioning of GxP systemsThe position will build on and oversee the existing GxP quality management systems, including establishing quality principles, procedures, audit plan, approach to address non-compliance, etc.This position is responsible for ensuring quality in company GxP activities performed by contractors as well as any internal GxP activitiesThe position will serve as the company's primary GMP and GDP expert and quality contact for contract manufacturers, and will oversee consultant experts for the company in GCP and GLP activities.As the company grows, the position will be responsible for building out the quality organization and preparing for more complex operations as multiple clinical trials are initiated and multiple projects, at various stages of the development are in the pipeline. QualificationsUndergraduate DegreeAt least 10 years of experience in a cGMP Quality role in the biotechnology industry working with biological manufacturingThorough understanding of GxP systems and quality principlesDemonstrated ability to understand regulations and guidances and translate understanding to practiceDemonstrated ability to work with business leads in a collaborative and supportive roleChondrial Therapeutics provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law.PM18ResponsibilitiesJob Duties/Responsibilities:Partner with the Chondrial team and third parties to ensure that proper quality standards are set and reliably metReview and approve GxP documentation, including manufacturing batch release packages, deviations and investigations, etc.Oversee the company's vendor qualification program, including engaging and overseeing external auditorsEnsure a Quality System continually compliant with GxPsBuild on the existing quality management system and work with the Manager, Regulatory and Quality Operations to maintain the systemEnsure internal and external team members are appropriately qualified and trainedWork with internal and external team to assist in solving problems and insuring compliancePrepare for and host inspections and auditsApproximately 25% travel requiredPI111406330Pandologic. Category: , Keywords: Quality Control / Quality Assurance Director

Keywords: Chondrial Therapeutics, Inc., Philadelphia , Director of Quality Assurance - Bala Cynwyd, Executive , Bala Cynwyd, Pennsylvania

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