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NONovartis

QA Compliance Lead(m/w/x)

Stein
Full-timeOn-siteSenior

Leading GMP compliance and inspection readiness for a global pharmaceutical company. 15+ years QA/Compliance experience in pharma/biotech required. Reasonable accommodation for medical condition or disability.

Requirements

  • Minimum 15 years progressive QA/Compliance experience in GMP pharma/biotech
  • Proven senior QA leadership in compliance strategy/inspection outcomes
  • Deep expertise in cGMP, Quality Systems, 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 or related discipline
  • Fluent English; German is a strong advantage
  • Communication skills and leadership

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

Benefits

Other Benefits

  • Reasonable accommodation for medical condition or disability
  • Detailed information about essential functions
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Novartis 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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