Director of Quality & Regulatory Affairs - Manufacturing

Quality Organization Leader Fast growing St. Louis Pharmaceutical / Medical Device / Dietary Supplement manufacturing and distribution firm is seeking an experienced professional to lead our Quality and Regulatory functions. This role would have direct responsibility for all compliance aspects of the organization (15-20 people) including Regulatory Affairs, Quality Assurance, Quality Control, Document Control and Safety and reports to the CEO. This person and his/her organization will be responsible for maintaining and continuously improving the overall Quality Management System as well as Regulatory Affairs for the Nomax/Amcon organization. This involves continually developing and maintaining the Quality System to ensure that the organization remains compliant with 21 CFR 110, 111, 210, 211 & 820 as well as ISO 13485 and the EU Medical Devices Regulation 2017/745. ESSENTIAL DUTIES AND RESPONSIBILITIES Manage and mentor Quality team, emphasizing teamwork, planning, follow-up, and effective communication. Product Quality: Ensure compliant and efficient batch disposition processes. Provide oversight and direction to the manufacturing processes to ensure compliance with specifications, standards, and product appropriate GMPs. Oversee APR (Annual Product Review) and product stability programs. Participate in Investigations and/or review investigations for all Deviation and OOS events. Coordinate the CAPA and Change Control Program. Customer Correspondence: Ensure receipt, documentation, investigation, and answer customer complaints. Coordinate all product recalls and notifications. Establish Quality Agreements with management and customers. Audits and Regulatory Compliance: As the head of the Quality Team, coordinate, host and respond to all regulatory and notified bodies audits. Answers to the audit points of concern will be coordinated and documented along with senior management and consultants if the situation requires. Coordinates the internal audit program including training of new auditors and ensuring corrective action plans are completed appropriately. Management Representative: Fulfill all the responsibilities for the Management Representative as stated in ISO 13485: 2016, the EU Medical Devices Regulation 2017/745 and other applicable regulatory citations. Monitor the manufacturing and Quality System process for compliance to applicable regulations and performs training as necessary to maintain compliance. QUALIFICATIONS Sounds decision making and problem-solving skills to choose the best solution. Ability to prioritize, organize and develop specific goals to accomplish the work for the department. Effective, clear communicator in both written and oral format. High degree of critical thinking by using logic and reasoning to identify strengths and weaknesses of alternative solutions, conclusions, or approaches to problems. Ability to collaborate with all levels of the Company. High level of attention to detail, dependability, and initiative. EDUCATION AND/OR EXPERIENCE Minimum Required: B.S. in Life Science, Engineering, or related field. Minimum Required: 7+ years related experience managing quality teams. SYSTEMS AND TECHNOLOGY Proficient in Microsoft Excel, Word, PowerPoint, Outlook Experience with both paper based and electronic QMS. Job Type: Full-time Benefits: 401(k) 401(k) matching Dental insurance Employee assistance program Flexible spending account Health insurance Health savings account Life insurance Paid time off Vision insurance Education: Bachelor's (Required) Ability to Relocate: St. Louis, MO 63123: Relocate before starting work (Required) Work Location: In person