Director Of Quality Assurance

Employment Type

: Full-Time


: Executive Management

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JOB SUMMARY: The Director of Quality Assurancemaintains systems to assurecompliance regulatory and client requirements for all relevant GMP operations carried out within theorganization for the manufacture of drug substances in compliance with FDA and internationalregulatory requirements for research, pre-clinical, clinical and commercial Active PharmaceuticalIngredients (APIs). Responsibilities: Maintain and improve the companys quality system per FDA ICH Q7 requirements for drug substances and ISO 13485 for raw materials used in device and diagnostics Familiarity with 21 CFR 210 and 211 Coordinate regulatory documents, such as Chemistry, Manufacturing and Controls (CMC) and Drug Master Files (DMF) to meet FDA cGMP and ICH requirements Serve as the secondary point of contact with regulatory agencies such as the FDA and foreign regulatory agencies, and participate in all regulatory inspections Host customer quality audits, coordinate quality agreements and change notifications with customers Coordinate supplier quality system and ensure critical suppliers are qualified through audits and questionnaires Develop annual master validation plan and ensure validations are conducted per ICH guidelines, including cleaning validations, process validations, facility and equipment qualification, and analytical test method validation Resolve day to day issues within functional departments and provide compliance assistance as needed Ensure continuous improvement and effectiveness of the quality management system Oversee and conduct GMP, ICH and ISO training to comply with regulatory requirements Chair management review meetings and oversee quality improvement plan Oversee CAPA, deviations, NCMR, and product complaint systems and ensure discrepancies are properly documented, investigated and completed in a timely manner Qualifications: Bachelors Degree in Science related field At least 10 years work experience in a Quality field for GMP company At least 5 years management experience ASQ, CQA and/or CQE certification desired Knowledge of GMP, ISO, Regulatory and FDA regulations
Associated topics: design, engineering, manufacture, product, product manager, production, program manager, quality

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