Associate Director, Clinical Quality Assurance (Clinical QA Program Lead)
Job ID: REQ-10071223
Location: Hyderabad, India
Job Type: Full-Time | Regular
Function: Quality | Clinical Development
Division: Development
Company: Novartis Healthcare Private Limited
Job Overview
Novartis is seeking an experienced Associate Director, Clinical QA (Clinical Quality Assurance Program Lead) to provide strategic quality oversight across development and research functions in India. This senior leadership role is responsible for ensuring compliance with global regulatory requirements, strengthening quality management systems (QMS), and driving inspection readiness across clinical and research operations.
The position plays a critical role in maintaining GxP compliance, supporting global and regional quality initiatives, and embedding a culture of quality excellence aligned with regulatory standards such as GCP, GLP, GMP, Pharmacovigilance (PV), and Investigator-Initiated Programs (IP).
Experience Required
Significant experience in Clinical Quality Assurance within pharmaceutical, biotechnology, or life sciences organizations
Strong background in GxP compliance including GCP, GLP, and cGMP environments
Proven experience in audit and inspection management, including health authority inspections
Demonstrated people management and leadership experience
Experience supporting global drug development and research functions
Hands-on experience with Quality Management Systems (QMS) implementation and oversight
Key Responsibilities
Clinical Quality Oversight and Compliance
Provide expert QA guidance to ensure compliance with internal quality systems and global regulatory requirements
Oversee implementation of risk-based GxP processes across development and research functions
Translate global QA strategy into operational compliance activities at regional and site levels
Audit and Inspection Management
Lead and facilitate regulatory inspection preparation, management, and follow-up
Support inspection readiness initiatives and ensure sustainable remediation of identified gaps
Drive root cause investigations, corrective and preventive action (CAPA) implementation, and effectiveness checks
Quality Management Systems (QMS)
Oversee development, monitoring, and execution of Quality Plans
Identify compliance gaps and implement strategic process improvements
Ensure timely escalation and oversight of deviations, incidents, and quality events
Contribute to continuous improvement based on audit findings, regulatory intelligence, and quality metrics
External Oversight and Vendor Management
Provide quality oversight of external service providers supporting research and development
Support audits of third-party vendors and ensure compliance with regulatory and company standards
Oversee IT systems used in clinical research and development to ensure GxP compliance
Leadership and Culture
Lead QA teams or cross-functional quality project teams
Promote a culture of quality excellence and “right first time” mindset
Collaborate with stakeholders across NIBR, GDD, and other development functions
Support diversity, inclusion, and quality-driven behaviors within the organization
Product Quality Reporting
Ensure timely reporting of technical complaints, adverse events, and special case scenarios within 24 hours
Oversee distribution of marketing samples where applicable
Core Competencies
Clinical Quality Assurance Leadership
Audit & Health Authority Inspection Management
Quality Risk Management
GxP Compliance (GCP, GLP, cGMP, PV)
Drug Development Lifecycle Knowledge
CAPA and Deviation Management
Quality Systems Implementation
Regulatory Intelligence and Inspection Readiness
Cross-Functional Stakeholder Collaboration
Why Join Novartis?
Novartis is a global healthcare leader committed to reimagining medicine and improving patient outcomes worldwide. The organization combines scientific innovation with a strong culture of collaboration, compliance, and operational excellence.
This Associate Director, Clinical QA role offers the opportunity to shape quality strategy within global drug development programs while working in a highly regulated and innovation-driven pharmaceutical environment.
Diversity, Inclusion & Accessibility
Novartis is committed to building an inclusive and diverse workforce representative of the patients and communities it serves. The organization provides reasonable accommodation during the recruitment process and throughout employment, in line with applicable policies and regulations.
This Associate Director, Clinical QA position in Hyderabad is ideal for senior quality professionals seeking leadership roles in clinical quality assurance, regulatory compliance, and global pharmaceutical development.
Apply now through The Pharma Daily to explore senior clinical quality assurance careers in India and advance your leadership journey in global drug development.
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