Job Description

Vice President, R&D Quality 

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