Associate Director, Quality Assurance Support

CSL Limited

Bern, Switzerland
On-site
Cgmp and compliance
Gxp records and documentation
Quality risk assessments
CSL Limited is seeking an Associate Director of Quality Assurance Support in Bern, Switzerland, to oversee quality management and compliance activities within its biotherapeutics operations. The ideal candidate will have extensive experience in quality assurance, strong collaborative skills, and a commitment to improving service quality in a regulated environment

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 and compliance with CSL standards and procedures.
  • Acts as Subject Matter Expert for complex deviations and changes during inspections and audits; collaborates with global QA Support Functions.

Matching Summary

Match Score: 85

CSL Limited is seeking an Associate Director of Quality Assurance Support in Bern, Switzerland, to oversee quality management and compliance activities within its biotherapeutics operations. The ideal candidate will have extensive experience in quality assurance, strong collaborative skills, and a commitment to improving service quality in a regulated environment.

Skills & Requirements

Must-have

  • cGMP and Compliance
  • GxP records and documentation
  • quality risk assessments
  • non-conformances, investigations, CAPAs
  • change controls
  • quality performance metrics
  • cross-functional and global projects
  • Subject Matter Expert for deviations
  • proactive QA oversight
  • quality decisions with stakeholders
  • new Quality on the Floor activities
  • complex deviations management
  • Quality Delegate for change management
  • GxP documentation approval
  • APR/PQR raw material data review
  • cross-functional Tier 1 meetings
  • GMP training and qualification

Nice-to-have

  • strong self-directed learning
  • build cross-functional networks
  • upskill colleagues
  • explain complex technical matters
  • effective stakeholder engagement

Key Requirements

  • 8+ years of experience
  • 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

Cover Letter