Development Quality Assurance Manager / Expert

About the role

The Development Quality Assurance Manager provides quality oversight for all Novartis entities in a country, ensuring compliance with Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GPvP) regulations and guidelines. The role covers quality and compliance of Development, Global and local Medical Affairs and commercial patient-facing projects, products and programs, and works closely with local Development colleagues, Medical Affairs and the Country Quality team.

Key responsibilities

• Oversee the local Quality System and written procedures so that GCP and pharmacovigilance processes comply with global requirements and regulations, including ICH GCP and GPvP guidance and the approval of local GCP/PV procedures.
• Support the local Quality Plan and use audit, inspection and KQI findings to drive continuous improvement.
• Ensure adequate training systems for GCP, GPvP and other development activities, with inspection-ready documentation.
• Drive clinical/PV QA investigations and CAPA implementation, and escalate GCP/GPvP non-compliance.
• Monitor the Quality System and KQIs to identify risks and work with business partners on root causes and mitigation plans.
• Lead or support GCP and GPvP inspections and Health Authority responses, and follow up on CAPAs.
• Partner with local and global teams on audits of clinical development and PV activities and verify corrective and preventive actions.
• Approve local CAPA documentation and manage CAPA closure.
• Handle QA activities for the qualification and requalification of external service providers (ESPs) supporting clinical or PV activities.
• Ensure processes for digital governance platforms and computerized systems meet GCP and GPvP requirements.
• Lead local quality review board meetings, communicate trends and risks, and coordinate the clinical and PV parts of the annual quality report.

Required profile

• Degree in Life Sciences or a related field.
• Fluent English, speaking and writing.
• Typically more than 5 years of experience in the pharmaceutical industry in quality assurance, regulatory affairs, pharmacovigilance or a related field, preferably at least 3 years in clinical development.
• Experience leading projects.

Required skills

• Quality Assurance and Quality Management Systems (QMS)
• CAPA management
• Data integrity
• Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GPvP)
• Inspection management and performance auditing
• Stakeholder management