Compliance Operations Manager

2 weeks ago


Glostrup, Glostrup Kommune, Denmark Agilent Full time

About the Role

Agilent is seeking a Compliance Operations Manager to support Quality Management Systems and external requirements. As a Global Quality Systems Lead, you will drive initiatives for continuous improvements and collaborate with international colleagues to achieve company goals.

Responsibilities

  • Support Agilent sites/divisions with Quality Operations, including CAPA, inspection/audit readiness, complex/systemic investigations, and remediation.
  • Serve as Global Process Owner for Nonconformity Management.
  • Support Agilent sites/divisions in adhering to Agilent QMS and applicable regulatory requirements and standards.
  • Lead and/or support complex investigations and drive risk-based actions, issue resolution, and continual improvement.
  • Support and/or lead cross-functional strategic projects in the compliance space.
  • Assess and update relevant GxP processes and systems as required.
  • Identify, maintain, and manage compliance activities across a Business Group.
  • Drive CAPA and effectiveness check requirements and improvements.
  • Partner with Business Quality representatives to develop and implement corrective and preventive actions.
  • Represent QCS/Compliance as a compliance SME during external audits and Health Authority inspections.
  • Support the continual improvement of processes and governance components.

Requirements

  • Bachelor's degree in science or a related field.
  • 5+ years of industry experience in a life science environment.
  • Experience with managing Quality Systems and/or Compliance in a life science/pharmaceutical environment.
  • Sound knowledge of ISO9001, ISO13485, MDSAP, IVDR, 21 CFR 820, 21 CFR 210/211, and 21 CFR pt. 11.
  • Excellent written and verbal communication skills.
  • Fluency in written and spoken English.

About Agilent

Agilent offers a great opportunity for you to make a significant impact and develop your skills in a world-class company that takes pride in developing new innovative solutions for labs around the world to improve cancer diagnostics.

Our company culture values passion, sharing, trust, and integrity. We offer a caring and fast-paced environment, and you will become part of a team that is passionate about what we do.

Agilent offers core global benefits to all staff, including a great salary, stock purchase plan, life insurance, pension, healthcare, physiotherapy, and more.

Travel and Work Environment

This job has a full-time weekly schedule and includes the option to work remotely.



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