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.