Vice President, Head of Quality R&D

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 / Develo…