What are the responsibilities and job description for the Associate Director Quality Assurance position at RBW Consulting?
RBW are collaborating with a growing CDMO to present an Associate Director, Quality Assurance role in NC.
With over 9 years in the industry and continued success in Commercial manufacturing, this organisation are looking to grow their offering to clients to including Biologic focused activity, covering both Commercial and Clinical partners. You will be responsible for:
- Process Management: Oversee the entire transfer process, including due diligence, feasibility studies, protocol/report preparation, PPQ, PAI readiness, and the implementation of quality system oversight.
- Audit and Compliance: Ensure audit readiness, support regulatory inspections, manage complaints effectively, oversee change control, review metrics, and conduct annual product reviews. This also involves developing robust quality systems and driving continuous improvement initiatives.
- Regulatory Compliance: Ensure adherence to all company policies and procedures, as well as compliance with applicable domestic and international regulations (GMP, etc.) Must include 21 CFR Parts 210, 211, 600, & 610
- Metrics and Reporting: Compile, analyze, and report on metrics, identifying trends and root causes to develop new initiatives and improve processes.
If you are looking to lead the development of a business unit, be part of a dynamic company, and to grow your own teams - get in touch to find out more about the opportunity.
