Reporting to the Vice President of Quality and Regulatory Affairs, the Director of GMP Quality Assurance will direct and provide leadership for all CMC activities of the Quality Assurance Department. This is a leadership/management position responsible for overseeing the GMP components of the Berg Quality Management System (QA review and approval, compliance activities, product release activities, quality systems, document control, and developing the strategy and policies of the GMP QA department). The position will provide quality oversight of Berg’s innovative investigational drug products for clinical sites per applicable cGMP, FDA, and other regulatory agency standards. Berg seeks an adaptable, disciplined, and dependable individual with both clinical and commercial experience.
The Director of GMP Quality Assurance will manage personnel, equipment and resources to support department objectives. Duties will include: