Senior Quality Assurance Lead

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

Flexsis is a company of the Interiman Group, one of the leading providers of personnel services in Switzerland. Thanks to our solid expertise as well as the competencies within the Interiman Group, we offer tailored solutions in personnel consulting.

For our client Novartis in Basel, we are looking for a reliable and motivated (m/f/d)

Senior Quality Assurance Lead – Medical Devices & Combination Products

Start Date: 01.01.2027

End Date: 31.12.2027

Extension: Possible

Key Responsibilities

• Lead and provide Quality Assurance support to global Technical Research & Development (TRD) project teams.
• Act as the global TRD QA representative in project sub-teams, quality boards, development gate meetings, and other strategic forums.
• Provide quality oversight, strategic guidance, and scientific/technical expertise across assigned development projects.
• Develop and implement project quality strategies aligned with TRD QA objectives, regulatory requirements, cGMP, and internal standards.
• Lead quality risk assessments, contingency planning, and strategic decision-making to ensure timely achievement of project quality deliverables.
• Proactively identify and manage quality risks, issues, dependencies, and cross-functional interactions.

Your Profile

• Extensive Quality Assurance experience in Medical Devices and/or Combination Products — mandatory.
• Broad and fundamental knowledge of quality standards, policies, and regulatory requirements relating to Drug Products, Medical Devices, and Combination Products.
• Proven experience in combination product development and in Quality Assurance and/or Quality Control functions.
• Strong understanding of cGMP requirements and quality systems within a regulated pharmaceutical environment.
• Experience working with Health Authority inspections, particularly FDA and EMA inspections.
• Experience with Notified Body inspections and an understanding of the regulatory requirements applicable to medical devices and combination products.
• Knowledge of regulatory CMC requirements and submissions, including INDs, IMPDs, NDAs, ANDAs, and MAAs.
• Experience supporting regulatory submission preparation and inspection readiness.