Senior QA Lead, Medical Devices & Combination Products

Flexsis; Basel; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

Novartis in Basel is seeking a reliable Senior Quality Assurance Lead for Medical Devices & Combination Products. The role focuses on leading QA support for global TRD projects and acting as the TRD QA representative in strategic forums.

The position requires extensive regulatory knowledge (FDA/EMA) and strong cGMP experience to ensure timely quality deliverables and seamless inspections readiness.

Qualifikationen

• Extensive QA experience in Medical Devices and/or Combination Products is mandatory.
• Strong knowledge of quality standards, policies, and regulatory requirements for devices and drugs.

Aufgaben

• Lead QA support for global TRD project teams.
• Represent TRD QA in project sub-teams and quality boards.
• Provide quality oversight and strategic guidance across development projects.
• Develop and implement project quality strategies aligned with regulatory requirements.
• Lead quality risk assessments, contingency planning, and decisions for quality deliverables.
• Identify and manage quality risks, issues, and cross-functional dependencies.

Kenntnisse

Quality Assurance

Medical Devices

Combination Products

Regulatory Compliance

FDA/EMA Inspections

cGMP Knowledge

Jobbeschreibung

Novartis in Basel is seeking a reliable Senior Quality Assurance Lead for Medical Devices & Combination Products. The role focuses on leading QA support for global TRD projects and acting as the TRD QA representative in strategic forums.

The position requires extensive regulatory knowledge (FDA/EMA) and strong cGMP experience to ensure timely quality deliverables and seamless inspections readiness.