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Senior Director, Regulatory Affairs and Quality Assurance
Raleigh, NC 27513 United States
The Sr. Director, Regulatory Affairs and Quality Assurance will be the primary point of contact for identifying and communicating global regulatory changes as well as provide oversight to the Quality and Regulatory Compliance functions within the company. This role will include managing regulatory submissions, monitoring and communicating changes in regulations and database training. Ensuring the Quality Management System (QMS) is in accordance with the client and company requirements. Providing oversight for all internal and external audit functions as well as review, plan and provide guidance on the implementation of corrective and preventive actions deemed necessary to ensure a quality environment. Overseeing the maintenance of the Company’s Learning Management System. Driving Quality and Regulatory Compliance initiatives to insure the company has a strategy to grow and sustain the organization proactively. Supervise and direct the QRC department and QRC professionals.
Bachelor’s or Master’s degree preferred or equivalent experience in pharmaceutical/biotech and clinical research management. Eight to ten years of experience in drug safety and pharmacovigilance, quality management principles and systems and/or drug development working with clinical and/or post-marketing products. Previous regulatory experience preferred.
North Carolina Biotechnology Center