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.