Vice President, Head of R&D Quality

Bioksha

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.