What are the responsibilities and job description for the Associate Director of Quality Assurance position at Green Life Science?
BASED FULL TIME, ONSITE IN TEXAS
The Associate Director of Quality Assurance (QA) leads the QA team, overseeing staffing, performance management, and professional development. This role ensures compliance with regulatory standards (FDA, EMA, GMP) and drives continuous improvement in QA processes to meet company objectives. Key responsibilities include managing QA activities, implementing cost-saving and efficiency initiatives, developing and enforcing QA policies and procedures, and overseeing audits and inspections.
The QA AD will also manage the QA budget, supervise supplier quality programs, and maintain relationships with regulatory bodies.
Key Responsibilities:
- Lead and manage the QA team, ensuring high performance and continuous development.
- Drive improvements in quality, productivity, and compliance with regulatory standards (GMP, FDA, EMA).
- Oversee QA policies, procedures, and systems, ensuring adherence to quality standards.
- Coordinate and manage audits, inspections, and supplier quality functions.
- Manage the QA budget and support cost-reduction and efficiency initiatives.
- Ensure compliance for clinical and commercial materials, and coordinate issue resolution.
- Develop training programs to enhance team competency and professionalism.
Requirements:
- 8 years of experience in QA and GMP
- Cell and Gene / Biologics experience
- CDMO experience
- Aseptic practices and cleanroom operations
- Auditing techniques
- Expert knowledge of GMP, FDA, and EMA regulations for Biologics, including Cell/Gene/Viral therapies
shannon@greenlsr.com / 857 400 7901
