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.