Clinical QA Program Lead — Hybrid (East Hanover)

Novartis; Suisse; Sur place; CHF 114 000 - 212 000; Plein temps

Avantages offerts par ce poste

Health insurance

Retirement plan

Parental leave (14 weeks)

Résumé du poste

Novartis is seeking an Associate Director and Clinical Quality Assurance Program Lead to provide proactive, risk-based quality oversight for a portfolio of clinical programmes. You will ensure inspections readiness and compliance with Health Authority expectations, supporting patient safety and trial integrity.

Based in a global, matrix environment, you will collaborate with cross-functional teams to drive quality strategies, manage incidents, CAPAs, and continuous improvement across trials.

Qualifications

• Bachelor's degree in life science or healthcare field.
• Extensive experience in regulated activities such as Good Clinical Practice or Pharmacovigilance.
• Experience in clinical development and/or Quality Assurance roles.
• Strong understanding of how clinical trials are run.
• Broad understanding of global Health Authority expectations in clinical development and product development science.
• Strong skills in GCP, clinical quality and/or clinical development.

Responsabilités

• Provide Clinical Quality Assurance leadership for assigned programmes and trials.
• Drive the quality strategy within the Global Clinical Team and Clinical Trial Team you support.
• Monitor delivery of the annual Quality Plan for your assigned programmes and studies.
• Oversee the proactive quality risk management process and inspection readiness.
• Work with teams to detect risks early and ensure they are resolved.
• Support governance for quality incidents and escalate promptly when needed.
• Answer day-to-day GCP questions with practical guidance.
• Partner to lead initiatives on internal monitoring and oversight of outsourced activities.
• Lead inspection preparation and follow-up, including CAPAs and trend-based improvements.
• Act as QA contact for defined trials and participate in continuous improvement streams.

Connaissances

Quality Assurance

GCP Knowledge

Pharmacovigilance

Quality Risk Management

Stakeholder Management

Project Management

Leadership

Regulatory Compliance

Formation

Bachelor's degree in life science or healthcare

Advanced degree in life sciences or healthcare

Description du poste

Novartis is seeking an Associate Director and Clinical Quality Assurance Program Lead to provide proactive, risk-based quality oversight for a portfolio of clinical programmes. You will ensure inspections readiness and compliance with Health Authority expectations, supporting patient safety and trial integrity.

Based in a global, matrix environment, you will collaborate with cross-functional teams to drive quality strategies, manage incidents, CAPAs, and continuous improvement across trials.