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 resources to effectively support Commercial Quality and Global Quality Compliance while maintaining governance oversight
Provide scientific and technical support to commercial Quality teams for g. complex deviations, OOS investigations, complaints, and product-related issues
Ensure effective handover from development to commercial operations
Drive alignment between R&D and Commercial Quality to ensure lifecycle continuity
Quality Governance, Risk Management & Decision Making
Lead quality risk management across development programs
Ensure timely escalation of critical quality issues
Maintain oversight of quality metrics and performance trends
Drive data-driven decision-making and continuous
Cross-Functional Leadership & Business Support
Partner with R&D, Regulatory Affairs, Technical Operations, and Supply Chain
Ensure smooth integration of new products into development quality processes
Inspection Readiness & Compliance
Ensure continuous inspection readiness for R&D activities
Support global regulatory inspections impacting development programs
Ensure compliance with FDA, EMA, and other global regulatory expectations
Qualifications & Experience
Education
Advanced degree in Life Sciences, Pharmacy, Chemistry, or related field
Experience
15+ years in pharmaceutical Quality of which at least 5+ years in an international environment.
Significant leadership experience in:
R&D / Development Quality
Commercial GMP Quality Operations (required but not primary ownership)
Demonstrated experience with:
Global regulatory submissions and health authority interactions
Technology transfer and vendor oversight
Global team leadership, including offshore models
Core Competencies
Deep knowledge of global cGMP requirements and development regulations
Strong analytical and problem-solving capabilities
Ability to operate at both strategic and operational levels
Strong leadership in matrixed, global organizations
Excellent communication and influencing skills
By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance.