The Director, Quality Assurance Operations leads and manages the quality operations activities and assures overall compliance of clinical and commercial manufacturing and global distribution activities. This role requires the ability to integrate technical, regulatory, and business opportunities cross-functionally to enable the organization to achieve and exceed the business goals in a cGMP compliant manner.

This position will oversee lot release operations and work performed by Contract Manufacturing Organizations (CMO), contract laboratories, and/or Commercial Business Partners ensuring timely delivery of quality products and services throughout the Global Supply Chain. The Director of Quality Assurance Operations is responsible for not only assessing and releasing clinical and commercial product, but also providing end to end quality oversight by leading change and engraining a quality culture.

This position requires deep understanding and proven application of cGMP regulations and international guidelines (ICH, ISPE, WHO, etc.). This knowledge would combine with clear decision making and align with quality risk management principles to demonstrate release of material appropriate for clinical and commercial use.

typical roles and responsibilities for Director Quality Assurance

  • Serve as Quality Operations tactical lead on core projects related to Chemistry, Manufacturing, and Controls (CMC), overseeing all QA operational compliance activities including requirements of Global Commercial Partnerships
  • Manage, mentor, and develop staff by providing strategic feedback and opportunities so they are successful and enjoy their careers
  • Provide leadership and direct the compliance oversight of CMOs and Partners associated with commercial drug substance, drug product, and/or finished product manufacturing and distribution
  • Disposition Drug Substance, Drug Product, and/or Finished Product as required
  • Manage Material Review Board (MRB) process for non-conforming materials
  • Ensure appropriate quality systems are in place to support product release in a compliant and timely manner, and routinely monitor performance in effort to optimize turnaround
  • Ensure compliance to Global Regulatory Requirements as they relate to CMC and Quality. Exercise judgement on complex quality issues using thorough understanding of quality philosophy and regulations

Requirements for Director Quality Assurance – Scientific

  • B.S. degree in a scientific discipline
  • 10-15 years of QA experience working in commercial quality operations in the pharmaceutical or biotechnology industry, with specific experience in GXP quality assurance auditing and GXP regulations, or combined experience working in Quality control and/or Manufacturing
  • Comprehensive working knowledge of local, state, federal, and international regulations pertaining to GXP and ICH guidelines
  • Complete and thorough understanding of regulatory compliance requirements for US FDA, European Union, and Health Canada
  • Disposition Drug Substance, Drug Product, and/or Finished Product as required
  • Prior experience with Health Authority Audits