Associate Director, Quality Assurance Support

CSL Behring

Bern, Switzerland
Cgmp quality oversight
Gxp records and documentation review
Quality risk assessments
Responsible for routine and non-routine quality oversight activities in collaboration with local operational units and qualification activities

Job Summary

  • Responsible for routine and non-routine quality oversight activities in collaboration with local operational units and qualification activities.
  • Ensures operational quality management according to cGMP to guarantee appropriate service quality for Value Streams and compliance with CSL standards and procedures.
  • CSL Behring is a global biotherapeutics leader driven by its promise to save lives, focused on serving patients’ needs by using the latest technologies.

Matching Summary

Responsible for routine and non-routine quality oversight activities in collaboration with local operational units and qualification activities.

Skills & Requirements

Must-have

  • cGMP quality oversight
  • GxP records and documentation review
  • Quality risk assessments
  • Non-conformances and investigations
  • CAPA and change controls
  • Quality performance metrics monitoring
  • GMP training and qualification

Nice-to-have

  • Cross-functional collaboration
  • Stakeholder engagement
  • Subject Matter Expert
  • Proactive QA oversight
  • Driving improvement initiatives
  • Coaching and mentoring

Key Requirements

  • 8+ years of experience
  • High degree of independence
  • Strong self-directed learning capabilities
  • cGMP and Compliance
  • Engineering & maintenance operations
  • Utility monitoring programs
  • Material management, warehousing & logistics
  • Quality control & analytical methods
  • Change control management
  • Deviation management
  • CAPA management
  • Strong collaboration skills
  • Coaching & mentoring skills
  • Excellent communication abilities
  • Strong influencing and presentation skills

Work Rights

Not specified

Tailored Resume

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