Sr Director, Quality Assurance

at Affinity Executive Search
Location Not Specified, Massachusetts
Date Posted July 8, 2022
Category Mining / Oil / Gas
Job Type Not Specified


My client is expanding and seeks a Sr Director, Quality Assurance to implement a QA program to support GMP, GLP, and GCP compliance in accordance with ICH, US, and EU regulations. The ideal candidate will take on the following tasks:

  • Establish and direct the internal quality management system and ensure it meets standards research, development, and commercial activities.
  • Establish and ensure quality metrics that comply with best industry standards and practices.
  • Provide appropriate Quality oversight of external vendors and establish vendor qualification processes, vendor audit plans, quality agreements and quality performance metrics.
  • Counsel, train, and interpret quality requirements to ensure the company and vendors maintain a state of compliance with quality and regulatory requirements.
  • Communicate significant quality risks that may impact product suitability or regulatory compliance to management team.
  • Oversee SOP development activities and updates.
  • Review and approve QMS documentation including controlled documents, training material, deviations, laboratory investigations, CAPAs and change controls.
  • Provide feedback to operational department heads regarding audits, plans, findings, CAPAs, and issue resolution.
  • Develop and deliver training programs to ensure compliance with GxP and ICH requirements.
  • Establish strong working relationships with external manufacturers and ensure alignment of Quality Systems and requirements with CDMOs.

The ideal candidate will possess the following qualities:

  • 15+ years of QA experience in pharma, including GMP expertise and experience working on NDAs.
  • Solid and demonstrable knowledge of GxP regulations, guidelines, and experience implementing QM systems.
  • Expertise with ICHQ9 Quality Risk Management principles.
  • Attention to detail with an ability to perform critical review of pharmaceutical development and manufacturing documentation.
  • Ability to independently solve problems and work cross-functionally.