Senior Quality Manager, Client Quality Management

About the role

The Senior Quality Manager, Client Quality Management at Ergomed Group (PrimeVigilance) is responsible for implementing and maintaining the quality system and training for assigned client projects, ensuring compliance with global regulations, PrimeVigilance, and client requirements. Day-to-day work includes overseeing project quality activities, driving quality improvement, managing client quality oversight, developing project-specific Quality Management Plans, handling audit, deviation, and CAPA activities, monitoring quality KPIs, and providing quality analysis for monthly reports. The role also involves collaborating with Quality Management, Quality Assurance, and Audit Management teams, supporting junior staff, and may include line management and training responsibilities. Based in Pune, Maharashtra, India, this is a full-time position.

What you’ll do

• Oversight of all project related quality activities
• Drive project related quality improvement and providing quality advice
• Client management including direct oversight for client quality related activities for project
• Develop and maintain a project specific Quality Management Plan
• May act as main point of contact for all audit related activities for project and involvement in Deviation and CAPA Management responsibilities
• Ensures relevant quality KPIs are established and monitored
• Provide quality content and analysis for project monthly reports
• Working closely with Quality Management, Quality Assurance and Audit Management teams ensuring all aspects of company and client's QMS are adhered to by the Project

What you’ll bring

• Life Sciences degree
• Strong previous pharmacovigilance experience including quality and compliance experience within a GxP environment
• Good organisational skills
• Attention to detail
• Excellent communications skills
• Good IT skills
• Leadership qualities

Nice to have

Line Management experience is desirable

Skills

Education

Life Sciences degree