Director of Quality Assurance, Sterile Drug Product Manufacturing

At Aldevron, we shape the future of medicine by advancing science in meaningful ways. Our team of dedicated, forward-thinking associates share this goal by combining best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. We believe people are our most valuable asset. Whether this is your first step on a rewarding career path or are a seasoned professional ready to take your career to the next level, we hire the best from all backgrounds and experiences. Aldevron is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health. This position is part of Quality and Regulatory Affairs located in Fargo, ND and will be fully remote. At Aldevron, we combine best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. You will lead the Regulatory Affairs department and report to the Vice President of Global Quality and Regulatory Affairs. The Director of Quality is responsible for the creation, implementation and maintenance of all Quality and release processes in compliance with all foreign and domestic regulatory and statutory requirements. This individual will help to provide the strategic direction and vision as well as the tactical leadership necessary to consistently improve. Job Responsibilities Maintains up-to-date knowledge and provides expertise in Quality, Sterile Drug Product Manufacturing, Compliance, Design Controls, Risk Management, and Statistical Techniques. Establishes and implements metrics like process capability, control charts, and measurement quality to monitor system effectiveness and improve quality. Ensures company operations comply with relevant regulations, standards, and guidance, especially for sterile drug product manufacturing, and helps maintain positive audit results. Performs Management Reviews, advises management on product/process issues, makes improvement recommendations, and escalates significant quality issues to clients and regulatory bodies as needed. Establishes in-process product inspection standards for aseptically produced and sterile drug products, serves as the primary Quality Assurance SME with regulatory agencies and clients, and provides expert interpretation of regulatory guidelines. Develops and enhances phase-appropriate QMS programs that comply with industry standards from development through commercialization GMPs, oversees Aldevron’s quality program, including auditing programs and the review of various reports and records. Creates a culture of sustainable quality through various programs, authors/reviews SOPs, communicates quality issues to the Executive Team, directs training programs for Quality personnel, hires and develops staff, and establishes goals for continuous improvement and professional growth. Qualifications Bachelor of Science required, life science related field preferred 10+ years of relevant experience in a quality position, including 3+ years of that experience in a lead, supervisory or managerial position Experience in a variety of areas of the Quality Management Systems, experience with regulatory audits, including direct interface with inspectors, and Aseptic and sterile manufacturing experience required Knowledge and expertise in principles and current Good Manufacturing Practices (GMPs) in a development through commercial application, required Strong knowledge foundation of FDA and EU regulations regarding the manufacture of biologics (210, 211, and 610 CFR and EudraLex Vol. 4), including regulatory inspection or support experience, preferred #LI-GC1 Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com . Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes. The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) . We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation.