Quality Assurance Director
Location: Atlanta
Working Situation: Onsite
Level: Director
Our client is a trusted CDMO dedicated to dedicated to improving the health and well-being of people worldwide. They are currently seeking a highly motivated and experienced Quality leader to join their team and contribute to their mission of delivering safe and effective pharmaceutical products to clients worldwide.
Key Responsibilities:
- Oversee all aspects of quality management systems to ensure compliance with regulatory requirements (FDA, EMA, etc.), local requirements and industry standards.
- Serve as the site's primary contact (with both customers and regulatory agencies) for the Site Quality Unit.
- Develop and implement Site Quality Plan, Quality Unit objectives and related procedures.
- Collaborate cross-functionally to address quality-related issues, deviations, and CAPAs, ensuring timely resolution and prevention of recurrence.
- Conduct audits and inspections to assess compliance and identify areas for improvement.
- Driving continuous improvement and cost reduction projects while ensuring a client-centric approach within the Quality organization.
- Recruit, develop, and mentor a high-performing Quality team, fostering professional growth and ensuring a skilled and motivated workforce.
Qualifications:
- Bachelor of Science with a preference for a Master's degree, in a pharmaceutical-related field.
- Minimum of 15 years of experience in pharmaceutical quality operations with 8+ years of leadership experience.
- Have previously and effectively led a sizeable organization with multiple levels and shifts.
- Strong knowledge of cGMP regulations and international quality standards.
Company Benefits:
- Generous PTO
- Competitive 401K Match
If you are interested in the role of the Quality Assurance Director, don't hesitate to apply today!
