Director, Quality Operations

Job description

Our Work Matters At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world. The Impact You Will Make Develop, direct and lead Quality Oversight of Pharmaceutical and Combination Products (Drug/Device) manufacturing production activities for St. Louis Operations in the following areas: current GMPs, Regulatory/CMC, deviation investigations, corrective and preventative actions, batch record review, environmental control program, regulatory inspections and audits, change management, and contemporary product and process validation. Supports the development, implementation and monitoring of Quality and Regulatory Compliance strategies for combination products at the Bridgeton Manufacturing site. Ensures the inspectional readiness of the site at all times and compliance with all applicable regulations within the scope of the manufacturing site’s activities. This position leads a team of managers and individual contributor direct reports with a wide range of quality compliance responsibilities within Quality Assurance. Role Responsibilities: - Lead and engage with cross functional teams as needed to support continuous improvement acti...