Senior Quality Director

Viatris

Competitive salary; bonus scheme available; benefi...
Leading audits and health authority interactions
Experience as qualified person (qp) for batch release
Ensuring eu and us fda gmp compliance
The Senior Quality Director will lead the MDR Quality Operations team to ensure compliance with EU and US FDA requirements while driving a strong Culture of Quality

Job Summary

  • The Senior Quality Director will lead the MDR Quality Operations team to ensure compliance with EU and US FDA requirements while driving a strong Culture of Quality.
  • This role requires direct interaction with Health Authorities like HPRA and FDA to maintain audit readiness and manage regulatory submissions effectively.
  • Viatris offers competitive salaries, excellent career progression opportunities, and an inclusive environment dedicated to building a diverse workplace.

Matching Summary

The Senior Quality Director will lead the MDR Quality Operations team to ensure compliance with EU and US FDA requirements while driving a strong Culture of Quality.

Salary

Competitive salary; Bonus scheme available; Benefits include health insurance and pension

Skills & Requirements

Must-have

  • Leading audits and health authority interactions
  • Experience as Qualified Person (QP) for batch release
  • Ensuring EU and US FDA GMP compliance
  • Managing Quality Management System implementation
  • Overseeing manufacturing packaging testing and release

Nice-to-have

  • Third party release and quality oversight experience
  • Lean manufacturing or lean lab experience
  • Medical Device Regulations and combination products knowledge
  • Strong leadership and team management skills
  • Vendor management program efficiency

Key Requirements

  • Experience leading audits and interacting with Health Authorities
  • Work experience as a QP releasing batches to market
  • Knowledge of Medical Device Regulations preferred
  • Leadership and team management experience required

Work Rights

Not specified

Tailored Resume

Cover Letter