DIRECTOR, QA OPERATIONS

The Director, QA Operations will be responsible for leading the QA Operations team to support internal and external manufacturing while promoting a quality and continuous improvement mindset to ensure the QMS in support of cGMP manufacturing is robust and compliant.

Essential Responsibilities

• Responsible for the quality operations in support of Organizational Manufacturing, Contract Manufacturing Organizations, and the Quality Systems
• Lead and drive accountability of a diversified team of Quality professionals responsible for cGMP manufacturing of early and late-phase clinical trial materials
• QA oversight of the construction, commissioning, qualification, and validation (CQV) of a commercial manufacturing facility and the subsequent process validation activities
• Conduct management responsibilities in accordance with company policies and applicable laws
• Prepare quality documentation, metrics, and reports by collecting, analyzing, and summarizing information and trends including failed processes, target turnaround times and disposition dates, number deviations per batch, Root Cause/CAPA activities, etc.
• Continually work to improve the effectiveness of QMS through the effective application of quality policies, objectives, audit results, analyses of data, and corrective/preventive actions
• Demonstrate effective change leadership by building strategic partnerships across functional areas to further departmental and organizational objectives

  Qualifications

• Bachelor’s degree in biology, biochemistry, or related life sciences
• 8+ years experience working in a pharmaceutical or biotechnology company
• Previous experience managing teams in support of internal GMP manufacturing preferred
• Solid understanding of drug development and manufacturing processes
• Demonstrated experience in implementing and managing quality systems

  If interested, please contact Cecelia@morrisexecutivesearch.com or 240-464-0156