Director of Quality and Regulatory in Fargo, North Dakota For Sale
Basic Functions:
The Director of Quality and Regulatory is responsible for the oversight and leadership for developing, implementing, and maintaining of all quality management systems across Aldevron's operating divisions. Along with the alignment of their associated interdependencies to assure compliance to domestic and international standards and regulations for cGMP. This position will engage in cross-functional and cross-company matrixed teams and also interfaces with all other areas within Aldevron.
Essential Functions and Skills:
Maintain a risk-based and scientific-based quality system
Ensure that GMP service platforms will carry out tactical day-to-day regulatory functions.
Monitor the regulatory environment globally and provide expertise and guidance in interpreting government regulations, agency guidelines, and internal policies to provide assessments of the impact of new and changing regulations.
Provide technical and organizational leadership and direction to quality and regulatory programs and activities.
Ensure all GMP operations are in compliance.
Knowledge/Education Requirements:
Bachelors Degree in Life Sciences, i.e., Biology, Chemistry, etc.
10+ years of relevant experience in a Quality position is required; 3+ years of that experience in a lead, supervisory, or managerial position.
Direct experience with regulatory audits, including direct interface with inspectors.
Knowledge of Quality Control/ Quality Assurance methodologies
Knowledge and expertise in principles and current Good Manufacturing Practices (cGMP) in a development through commercial application.
Strong knowledge foundation of FDA and EU regulations regarding the manufacture of biologics (210, 211, and 610 CFR and EudraLex Vol. 4)
Experience in various validation topics which include Process, Cleaning, Equipment, Utilities, and IT Systems.
Strong communication skills. Both written and verbal
Aldevron is a custom manufacturing organization that provides plasmid, protein and antibody development and production services. Headquartered in Fargo, ND with locations in Madison, WI and Freiburg, Germany we constantly look to innovate and advance life science through collaborative partnerships. Aldevron works with leaders in pharmaceutical, biotech and research institutions around the world to accelerate the development of drug, treatment and preventions for numerous diseases and genetic disorders. Our reputation for innovative solutions for our clients has allowed us to expand our organization and offerings in all service platforms.
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