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

Merck & Co., Inc., Rahway, NJ, USA

Schachen, Switzerland
Responsible person for batch release
Swissmedic technical interpretation compliance
Batch record reviews and certification
The Biologics drug substance manufacturing facility at Schachen is a premier, state-of-the-art facility enabling and advancing best work for early clinical supply

Job Summary

  • The Biologics drug substance manufacturing facility at Schachen is a premier, state-of-the-art facility enabling and advancing best work for early clinical supply.
  • The Site RP is a key member of the Quality Leadership Team, responsible for ensuring site compliance with Swissmedic Technical Interpretation (I-SMI.TI.17).
  • Responsibilities include batch release, deviation investigations, audit oversight, and managing major change notifications to health authorities.

Matching Summary

The Biologics drug substance manufacturing facility at Schachen is a premier, state-of-the-art facility enabling and advancing best work for early clinical supply.

Skills & Requirements

Must-have

  • Responsible Person for batch release
  • Swissmedic Technical Interpretation compliance
  • Batch Record reviews and certification
  • Deviation and OOS investigations
  • Internal audit program oversight
  • Health Authority Major Change Notifications

Nice-to-have

  • Cross-functional teamwork and collaboration
  • Continuous improvement initiatives
  • Permanent Inspection Readiness
  • Cutting edge compliance skills

Key Requirements

  • Bachelor's degree in Life Science
  • 10+ Years in Quality Role
  • Eligible as Responsible Person per I-SMI.TI.17
  • Previously acted as a Responsible Person
  • Experience with Quality enterprise systems

Work Rights

Not specified

Tailored Resume

Cover Letter