The Senior Director, Quality leads the organization's Quality Assurance, Quality Control and Regulatory Affairs organization and oversees and supervises all aspects of quality and regulatory compliance. The Senior Director, Quality manages QA, QC, and RA teams as well as manages relationships with, and performance by, key service partners such as raw material suppliers and contract laboratories. The ideal candidate has a strong understanding of current Good Manufacturing Practice regulations, excellent communication skills, and substantial experience in quality assurance. Specific responsibilities include: Ensuring compliance with regulatory, FDA, customer, and internal cGMP requirements. Establishing a strong Quality and compliance culture. Overseeing the manufacture and testing of products that conform to specifications. Identifying, monitoring and mitigating risks. Streamlining the quality procedures and ensuring compliant and efficient product release. The incumbent also leads interactions with Customers, Product Development, Sales and Supply Chain leadership to develop systems and procedures that meet internal and customer quality requirements. The Senior Director, Quality maintains a close relationship with Operations and leverages R&D initiatives to manufacture high quality products, and achieve quality design and production goals. 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.