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 you 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 the Quality department located in Fargo, ND and will be On-site. You will be a part of the Quality Assurance Department and report to the VP of Quality responsible for creating and executing on the Quality Assurance Strategy.
Job Responsibilities:
- 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.
- Supports the company in assuring it is operating in accordance with applicable regulations, standards and guidance related to clinical and commercial activities and helps maintain positive audit results.
- Serve as the site's primary contact with both customers and regulatory agencies regarding quality/compliance issues and negotiate Quality Agreements.
- Develop and enhance phase appropriate QMS programs that comply with industry standards for development through commercialization GMPs including but not limited to establishment of quality agreements, management of lot review audit programs, implementation of QA review for Master and Executed Batch Records, development and oversight of processes supporting inspection and release of incoming raw materials, and implementation of in-process quality assurance review.
- Oversee and manage all aspects of quality functions for quality systems Product Complaints, Product Quality Review, Lot Disposition (raw materials to finished Product release).
- Establish and implement metrics (process capability, control charts, measurement quality, etc.) for monitoring system effectiveness to enable sound quality decisions and to improve quality.
- Provide leadership and management to direct reports including day-to-day supervision, performance management, training, and planning while leveraging team member skills and abilities to ensure goals are achieved.
Qualifications:
- 10+ years of relevant experience in a quality position, required with a minimum of 3 years in a managerial position.
- Experience with final drug product manufacturing with incoming Quality Management Systems, Quality Assurance and regulatory audits required.
- Bachelor of Science required; life science related field, preferred.
- 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.
- Ability to manage priorities, track progress of key projects, and provide updates to leadership as required.
It would be a plus if you also possess previous experience in:
- Experience working in a matrix environment.
- Experience implementing and executing on cGMP Quality Strategy.