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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 Global Quality Hub    Provide leadership oversight of the Hyderabad-based Quality organization supporting:   Global Quality Compliance activities  Commercial Quality Operations  Establish and maintain a scalable offshore operating model with clear:   Roles and responsibilities  Performance metrics  Governance and escalation pathways  Ensure alignment of offshore activities with global quality standards and expectations  Develop organizational capability, talent pipeline, and leadership within the Hyderabad team  Interface with Commercial Quality  and Global Quality Compliance    Enable Hyderabad resour