Associate Director, Clinical QA

Roles & Responsibilities:
• Provide QA expertise and compliance oversight to development and research functions
• Ensure implementation of quality risk-based and GxP-relevant processes within the Quality Management System (QMS)
• Lead and manage QA teams or quality project teams in collaboration with business partners
• Translate QA strategy into operational and compliance activities with risk-based execution
• Identify and close quality and compliance gaps; drive sustainable process improvements
• Monitor implementation of Quality Plans and support inspection readiness activities
• Participate in regulatory inspection preparation, management, and follow-up
• Oversee quality management of external service providers and IT systems supporting R&D
• Facilitate audits and inspections; ensure timely CAPA development and implementation
• Ensure timely escalation and oversight of deviations/incidents including root cause analysis
• Contribute to lessons learned from audits, inspections, and regulatory intelligence
• Report technical complaints/adverse events within 24 hours as applicable
• Manage distribution of marketing samples where applicable

Qualification:
• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or related discipline

Experience:
• Strong experience in Quality Assurance within drug development
• Experience in Audit & Inspection Management
• Exposure to Quality Management Systems and GxP environments
• People management experience preferred

Skills:
• Strong knowledge of cGMP, GLP, GCP, PV, and GxP regulations
• Expertise in Quality Compliance and Risk Management
• Experience in Drug Development lifecycle
• Leadership and stakeholder management skills
• Strong analytical and problem-solving abilities
• Excellent communication and collaboration skills

About the Organization:
Novartis is a global healthcare company committed to reimagining medicine to improve and extend people’s lives. With a strong focus on innovation, quality, and compliance, Novartis operates across research, development, and commercialization while fostering an inclusive and diverse work environment.