Director of Quality


Science and Research

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Frederick, MD - Professional - (USA) 7470 New Technology Way (Professional) MD Frederick , MD 21703

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Job Description

Director of Quality

Frederick, MD

Do 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, e.g., 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, e.g., 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 audits

Interested? 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 clearance

This 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!