Director of Quality

Frederick, MD
Apr 17, 2019
Apr 17, 2019
Full Time
Director of QualityFrederick, MDDo you bring 8+ years of Quality Management experience? Does your experience include working in a small biopharmaceutical company producing Phase I/II clinical materials, including vaccines and biotherapeutics? In this position, you'll be responsible for all aspects of quality assurance, from strategic planning to hands-on implementation, including:* Be responsible for the strategy, implementation and leadership of the QA and Regulatory function* Be accountable for the execution and administration of the GxP quality system pertaining to GMP and relevant ICH, US, and EU regulations* Manage a group of at least 35 employees reporting into 8 quality assurance functions* Ensure appropriate quality oversight of external vendors, eg, contact manufacturing organization (CMO), contract testing labs (CTL)* Plan and oversee day-to-day activities of the quality function including management of consultants, external auditors, internal quality functions, eg, continuous improvement, training, compliance, document control, lot release, regulatory affairs, validation/calibration, and computer systems validation* Lead preparations and management of regulatory inspections and client auditsInterested? Well qualified candidates will bring:* A Bachelor's degree in a related field of study, a Master's degree is preferred* Experience working in a small biopharmaceutical company producing Phase I/II clinical materials, including vaccines and biotherapeutics* At least twelve (12) years of experience in Quality Assurance including at least eight (8) years of management experience* Regulatory Affairs Certification (RAC) * Extensive knowledge and experience in GxP and QA principles, practices, regulatory and industry standards* Experience with using risk-based principles and decision making to ensure compliance at all stages of development* Strong negotiation skills* Must be able to obtain and maintain a clearanceThis position comes with a generous salary and complete benefits package close to home in Frederick.Apply today learn more about the Director of Quality position!

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