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Senior Director, Quality
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Full-time
- Maintain strict compliance to pharmaceutical and medical devices standards to ensure regulatory, FDA, customer, and internal cGMP requirements by leading the Quality Control, Quality Assurance and Regulatory Affairs teams.
- The Senior Director, Quality works with Senior Leadership in the identification of strategic goals and plans, advises company management in FDA regulatory policy and program matters, and recommends appropriate courses of action, along with overseeing relationships with Customers to ensure accurate technical information, specifications and resolve customer complaints.
- Manages the design and implementation of quality-related training programs for Quality Control, Quality Assurance, R&D, Regulatory Affairs and Operations personnel in performing required tests, decision making skills, statistical process control, and other areas as needed.
- Participates as part of new project design team and reviews new products, product design and product packaging, and makes recommendations for product, pharmaceutical product safety and environmental compliance.
- Represents the Company, as directed by Managing Director, Business Operations, in discussions with customers, suppliers, auditors, and regulatory agencies of the county, state, and federal government (FDA, etc
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