Responsible Person Dir Quality Assurance (m/f/d)

Muckelab

Schachen, Canton Lucerne, CH
Batch record review and certification
Quality management system oversight
Regulatory inspection support
The Site RP is a key member of the Quality Leadership Team responsible for ensuring compliance with Swissmedic Technical Interpretation standards

Job Summary

  • The Site RP is a key member of the Quality Leadership Team responsible for ensuring compliance with Swissmedic Technical Interpretation standards.
  • The role includes oversight of batch release, audits, deviations, CAPA, and regulatory interactions to maintain permanent inspection readiness.
  • The position requires strong collaboration across functions to resolve compliance issues and drive continuous improvement in quality processes.

Matching Summary

The Site RP is a key member of the Quality Leadership Team responsible for ensuring compliance with Swissmedic Technical Interpretation standards.

Skills & Requirements

Must-have

  • Batch Record review and certification
  • Quality Management System oversight
  • Regulatory inspection support
  • Audit program management
  • Deviation and CAPA management
  • Cross-functional collaboration
  • Quality enterprise systems expertise

Nice-to-have

  • Mentoring and coaching auditors
  • Project management skills
  • Innovation in compliance processes
  • Effective communication skills
  • Change management leadership
  • Risk communication
  • Continuous improvement facilitation

Key Requirements

  • Bachelor’s degree or higher in Life Science
  • 10+ years in Quality role in sterile/low bioburden biologics manufacturing
  • Eligibility as Responsible Person per I-SMI.TI.17
  • Previous experience as Responsible Person
  • Experience with LIMS, SAP-Quality, MES, Veeva Q-Docs
  • Experience supporting Swissmedic inspections

Work Rights

Not specified

Tailored Resume

Cover Letter