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 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.