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

Newyorkbioconnect

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 I-SMI.TI.17

Job Summary

  • The Site RP is a key member of the Quality Leadership Team responsible for ensuring compliance with Swissmedic Technical Interpretation I-SMI.TI.17.
  • Responsibilities include batch release support, audit leadership, CAPA management, and oversight of quality agreements and regulatory notifications.
  • The role requires active collaboration across functional areas to maintain inspection readiness and continuous improvement in quality systems.

Matching Summary

The Site RP is a key member of the Quality Leadership Team responsible for ensuring compliance with Swissmedic Technical Interpretation I-SMI.TI.17.

Skills & Requirements

Must-have

  • Batch Record review and certification
  • Quality Management System oversight
  • Regulatory inspection support
  • Audit program leadership
  • Deviation and CAPA management
  • Cross-functional collaboration
  • Risk management and compliance

Nice-to-have

  • Mentoring and coaching auditors
  • Project management skills
  • Strong communication skills
  • Innovation in quality processes
  • Change management leadership
  • Client relationship building
  • Diversity and cross-cultural awareness

Key Requirements

  • Bachelor’s degree in Life Science
  • 10+ years in Quality Role in Sterile/Low Bioburden Biological Drug Substance Manufacturing
  • Eligible as Responsible Person per I-SMI.TI.17
  • Experience with LIMS, SAP-Quality, MES, Veeva Q-Docs
  • Experience supporting Swissmedic inspections

Work Rights

Not specified

Tailored Resume

Cover Letter