Mantell Associates is partnered with a rapidly growing CDMO on their search for a Director of QA for their unique site based in Massachusetts, who will be an integral member of the site leadership team. Do you hold over five years of experience in a quality leadership role within the Biologics arena?
Our client is one of the most innovative organisations on the market making a breakthrough, committed to producing complex biological products and therapies. On a mission to bring life-changing therapeutics to patients to advance global health. This organisation has formed a clear strategy to continue building capabilities and new facilities with the latest technology platforms to meet growing client needs. You will get the opportunity to work with some of the brightest minds in the industry and join a diverse and inclusive business offering you limitless career progression.
Responsible for all aspects of Quality Assurance (QA), Quality Management System (QMS), Supplier Quality and the Quality Operations Group (QOG).
Working cross-functionally and tracking projects from start to finish.
Providing leadership and strategy to ensure that all products/services are aligned with quality standards, regulations (FDA and other notified regulatory bodies) and customer/regulatory requirements.
Demonstrate knowledge of department practices and company policies, creating goals for the department and supervising/guiding internal audits to transform and create a site culture of compliance excellence - reporting to the top management on performances/improvements.
Oversee team members and ensure performance levels meet corporate, Quality and business objectives.
Bachelor’s degree in a scientific/technical area (MS will be a huge advantage)
5+ years’ experience in leading Quality in a GMP environment (Biologics/Pharma)
Experienced in working closely with areas incl. Manufacturing, Engineering & PD.
Extensive knowledge of FDA and EMA regulatory requirements
Capable of applying GMP regulations and international standards to all aspects of the position