Vice President, Head of R&D Quality
Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com. Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.Job Description Vice President, R&D Quality Position Summary The Vice President, R&D Quality is accountable for the global leadership and oversight of Quality across product development, clinical supply, and regulatory submissions. The role ensures that all R&D Quality activities are executed in compliance with global regulatory requirements and aligned with a robust, inspection-ready Quality Management System. The VP, R&D Quality provides also strategic and organizational oversight of offshore Quality resources based in Hyderabad, which support Global Quality Compliance and Commercial Quality Operations. This oversight is focused on governance and performance management. Key Responsibilities Leadership of Global R&D Quality Define and implement the R&D Quality strategy aligned with corporate and regulatory expectations Ensure oversight of: CMC development documentation and submission readiness Clinical Trial Material (CTM) release and compliance Registration and validation batches supporting global filings Drive right-first-time quality of data and documentation supporting regulatory submissions Ensure effective application of: Change control, deviations, investigations, and CAPA processes Method validation, transfer, and analytical lifecycle management Quality Oversight of Development Lifecycle Provide executive oversight of: Technology transfers from R&D to GMP vendors and across manufacturing sites Qualification and oversight of pre-commercial vendors (CMOs, CROs, laboratories) Ensure robust governance of quality activities supporting new product registrations Approve critical quality decisions related to R&D activities, including: CMC data packages prior to submission CTM release Deviations, OOS, CAPAs, and change controls for development products Oversight of Hyderabad ...