Vice President, Quality and Regulatory Affairs

The Vice President, Quality and Regulatory Affairs leads enterprise-wide quality, compliance, and regulatory initiatives in support of NYBCe’s GxP Business Units, including Blood and HCT/P manufacture, analytical laboratories, specialty pharmacy, therapeutics and medical programs. Reporting to the SVP of Quality and Regulatory Affairs, the VP provides focused oversight of quality systems to ensure compliance with regulatory and corporate requirements. She/he oversees quality-related interactions with clients, including customer audits and the development of quality agreements. The VP establishes a regulatory strategy for product development projects, advises NYBCe leadership on regulatory issues, prepares regulatory submissions, and represents NYBCe to regulatory and accrediting agencies. The VP applies strong leadership skills to motivate, coach, develop, and retain high-performing Quality staff, and fosters a quality-oriented culture throughout the organization. Responsibilities: Lead improvement pro-jects dealing with broad or complex issues, or with strategic impact. Participate in preparation of CMC submissions. Locations: Candidates must be able to report into one of the following NYBCe locations: Rye, New York; Kansas City, Missouri; St. Paul, Minnesota; Providence, Rhode Island, and Newark, Delaware. For applicants who will per-form this position in New York City or Westchester County, the proposed annual salary is $270,000.00p/yr. to $280,000.00p/yr. Click here to apply.