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The Head of Quality Biologics Drug Substance Manufacturing
The Head of Quality Biologics Drug Substance Manufacturing is accountable for the overall budget of approximately $200M+ and financial performance for the Biopharmaceutical Quality network. He/she is directly responsible for Quality and Compliance activities and organization across the Biopharmaceutical Drug Substance Manufacturing network to include: product testing (QC), product assessment and release (QA), Quality auditing and inspection readiness, product quality management and implementation of the Quality System at Manufacturing Site level.
He/she is also accountable for ensuing proactive site cGMP inspection readiness programs are established and operational and responsible for providing Quality input to Global Quality organization and establishing working relationships with global regulatory authorities and key industry groups. As the head of the department, the individual will also take responsibility for organization design and implementation to include staffing, talent management, budgeting and resource allocation.
This role requires a Bachelorís degree, though a Masterís degree in Chemistry, Biology Engineering or other Science is preferred. The individual must have 15 or more years of experience in pharmaceutical Quality and Compliance or related operational leadership roles. He/she must be an expert in Quality and Compliance principles and requirements and have an established track record of successful regulatory inspections. Experience in multiple technical platforms (bio, pharma, device, aseptic processing) is also required. The ideal candidate will have international experience.
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