Senior Director, Quality

About the role

Set strategy and vision for Kansas City campus for Quality Operations, specifically the Quality vision, culture, and strategic imperatives for the Quality organization and deliver on all business objectives through strong alignment with General Managers and their vision for their site. Ensure a sustained state of compliance with a strong focus on Continuous Improvement (CI), finding flexible and compliant solutions for the business (strong risk management skills). Serve as the campus's primary contact (with both customers and regulatory agencies) for the site Quality Unit ensuring expectations are met consistently and at a high level. Ensure the campus meets requirements for drug and combination product manufacturing across product technologies including Clinical Supply, Biologics and Analytical Services. Develop and implement the campus Quality Plan by segment, Quality Unit objectives and related procedures and maintain an effective Quality Management System (QMS) across the campus that aligns with regulatory requirements/expectations. Monitor site compliance to FDA, EU and all other applicable requirements and ensure regulatory and customer audits are managed successfully and any responses submitted in a timely manner. Direct a team of Quality professionals. Provide development and disciplinary actions (as needed) to assure the department remains engaged and motivated. Part of the Site Leadership Team (and campus) representing the QRA function for the site, supporting site mission/strategy and prepare, approve, and manage Quality departmental budget. Approve or reject, starting materials, packaging materials, and intermediate, finished products, and to evaluate batch production records. Ensure that all necessary QC testing is performed on manufactured products supporting and meeting business objectives and on-time deliveries. Ensure Quality approval of specifications, sampling instructions, test methods and other Quality Control procedures. Review and approve Site Annual Product Reviews and ensure that required validation activities are completed. Responsible for ensuring environmental monitoring and control of the manufacturing environment and plant hygiene. Ensure the proper designation and monitoring of storage conditions for materials and products. Actively participate in ensuring business measures/metrics are met (e.g. Customer service) Ensure that Document Control activities are compliant with FDA, EU and other applicable requirements and that controlled documents are maintained in an orderly manner to allow rapid retrieval when required. Other duties as assigned The Candidate: Bachelor of Science required; MS preferred in Qual