Director of Quality Assurance

Overview

Our client is hiring a Director of Quality to support their strong, ongoing quality standards. This role will report to the President of the organization and be involved in pivotal decisions for the site. They are a small, GMP organization who has a history of quality first decisions. They are looking for this Director to continue with the strong quality mindset while also making physical and process updates to the site and with the team.

• Responsible for all quality assurance and quality systems activities
• Responsible for the direction of quality assurance staff and all floor-level activities in manufacturing, packaging, and distribution
• Maintain and improve the level of cGMP compliance, and ensure that all operations are performed in accordance to cGMP, ICH, FDA guidelines, and all quality initiatives
• Conduct investigations, root cause analysis, and implement corrective and preventative actions (CAPA’s)
• Perform internal and external audits, including those of contract manufacturers, laboratories, and suppliers; prepare reports of audit findings and corrective actions
• Represent the company during FDA and customer audits

• 5+ years in pharmaceutical quality with supervisory experience and a comprehensive understanding of FDA regulations and cGMP’s