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NONovartis Pharma Stein AG

QA Compliance Lead(m/w/x)

Stein
Full-timeOn-siteManagement

Leading GMP compliance and inspection readiness for a pharmaceutical company. 15+ years QA/Compliance experience in pharma/biotech required. Supportive work environment, professional development opportunities.

Requirements

  • Minimum 15 years progressive QA/Compliance experience in GMP pharma/biotech
  • Proven senior QA leadership track record
  • Deep expertise in cGMP, Quality Systems, regulatory frameworks (EMA, FDA, Swissmedic)
  • Extensive experience leading health authority inspections, audits, remediation
  • Strong credibility and executive presence with stakeholders
  • Ability to lead, influence, and challenge senior management
  • University degree in Life Sciences, Pharmacy, Chemistry, Biotechnology
  • Fluent English; German advantageous for Switzerland

Tasks

  • Lead Quality Compliance activities
  • Ensure GMP compliance
  • Act as senior quality authority for audits
  • Maintain inspection readiness
  • Develop Quality Management System
  • Manage deviations, CAPAs, change control
  • Ensure data integrity
  • Govern GxP risk management
  • Manage compliance remediation
  • Oversee regulatory and quality activities
  • Monitor suppliers and service providers
  • Promote quality culture
  • Model integrity and accountability
  • Partner with senior stakeholders
  • Coach senior quality professionals
  • Develop sustainable expertise
  • Champion Lean Leadership
  • Drive operational excellence

Work Experience

  • 15 years

Education

  • Bachelor's degree

Languages

  • EnglishFluent
  • Germanis a plus

Benefits

Other Benefits

  • Reasonable accommodation for medical condition or disability
  • Detailed information about essential functions

Informal Culture

  • Supportive and inspiring work environment

Learning & Development

  • Opportunities for professional development

Career Advancement

  • Talent network for career opportunities
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Novartis Pharma Stein AG and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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