Associate Director – Clinical Quality Assurance (CQA)
Location: India | Job Type: Full-Time | Category: Clinical Quality Assurance / GxP Compliance
About the Role
Novartis is seeking an experienced Associate Director – Clinical QA to lead and oversee quality assurance and compliance across clinical development and research functions. This senior leadership role is responsible for driving adherence to global quality management systems, ensuring compliance with regulatory requirements (GCP, GLP, GMP, PV, IP), and promoting a culture of quality across the organization.
The Associate Director will serve as a quality champion, providing strategic oversight, implementing risk-based QA initiatives, and supporting inspection readiness for internal and external audits. This role requires a proactive, results-driven professional capable of translating quality strategy into operational excellence across global, regional, and country functions.
Key Responsibilities
Quality Oversight and Compliance
Provide expertise in Clinical QA to ensure compliance with GxP-relevant processes and quality system requirements.
Lead implementation of risk-based quality strategies, ensuring sustainable process improvements and adherence to regulatory standards.
Monitor and drive corrective and preventive actions (CAPAs) for deviations, incidents, audits, and inspections.
Oversee quality management of external vendors, IT systems, and research service providers supporting development programs.
Leadership and Team Management
Lead and mentor QA teams and cross-functional quality project groups to achieve compliance and operational excellence.
Collaborate with business partners and other QA functions to ensure alignment with regulatory requirements and organizational goals.
Promote a culture of “right-first-time” quality behaviors, supporting continuous learning and proactive risk management.
Regulatory Inspection Readiness
Support preparation for regulatory inspections, including planning, participation, and follow-up.
Ensure timely reporting of technical complaints, adverse events, and special cases related to Novartis products.
Provide quality oversight for deviations, incidents, and investigations with root cause analysis and effective CAPA implementation.
Process Improvement and Strategy Execution
Translate QA strategies into operational and compliance activities across clinical development programs.
Implement procedural updates, training programs, and effectiveness checks to enhance quality performance.
Drive lessons learned and proactive risk-based behavior through audit results, regulatory intelligence, and metrics.
Required Experience and Qualifications
Experience: Minimum 10+ years in Clinical Quality Assurance or related roles within pharmaceutical, biotech, or clinical research organizations; 5+ years in leadership or managerial capacity.
Strong knowledge of Quality Management Systems (QMS), GxP standards, clinical research compliance, and regulatory inspection requirements.
Expertise in audit management, process improvement, deviation/incident handling, and CAPA implementation.
Proven leadership skills in managing QA teams and collaborating with cross-functional stakeholders.
Excellent communication, analytical, and problem-solving skills.
Advanced understanding of regulatory guidelines including GCP, GLP, GMP, PV, and IP.
Commitment to diversity, equity, inclusion, and accessibility in the workplace.
Education: Bachelor’s or advanced degree in Life Sciences, Pharmacy, Medicine, or related scientific discipline.
Why Novartis?
At Novartis, we combine innovative science with a community of passionate professionals working together to transform patient outcomes. Joining our team means contributing to breakthroughs in healthcare while developing your leadership, strategic, and technical skills in a global, collaborative environment.
Accessibility and Accommodation:
Novartis is committed to providing reasonable accommodations to individuals with disabilities. Applicants requiring accommodation during the recruitment process should email diversityandincl.india@novartis.com with the job requisition number and details of the accommodation required.
Apply Today:
Take the next step in your career with Novartis and play a pivotal role in shaping clinical quality assurance on a global scale. Submit your application on thepharmadaily.com to join a team dedicated to scientific excellence and patient impact.
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