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Global Quality Assurance Specialist

2 months ago


Glostrup, Glostrup Kommune, Denmark Agilent Full time
About Agilent

Agilent is a world-class company that takes pride in developing new innovative solutions for labs around the world to improve cancer diagnostics. We offer a dynamic and inclusive work environment where you can make a significant impact.

Salary

We offer a competitive salary, ranging from $90,000 to $130,000 per year, depending on location and experience. Our pay ranges are determined by role, level, and location. Additionally, we provide a range of benefits, including core global benefits, Agilent Result Bonus, Stock Purchase Plan, Life Insurance, Pension, Healthcare, Physiotherapy, and more.

Job Description

We are seeking a skilled Compliance Operation Lead to join our Global Quality team. As a Compliance Operation Lead, you will be responsible for supporting compliance with Agilent's Quality Management System (QMS) and external requirements. You will drive initiatives to ensure continuous improvements of our processes and collaborate with international colleagues to achieve company goals.

Key Responsibilities
  • Support Agilent sites/divisions with a broad spectrum of Quality Operations support, including CAPA, inspection/audit readiness, complex/systemic investigations, remediation, and process transformation.
  • Serve as a Subject Matter Expert for Quality & Compliance issues, lead and/or support complex investigations, and help drive risk-based actions, issue resolution, and continual improvement across the network.
  • Partner with Business Quality representatives to develop and implement corrective and preventive actions based on trends and identification of systemic issues.
Required Skills and Qualifications

To succeed in this role, you will need:

  • A Bachelor's degree in science or a related field.
  • 5+ years of industry experience in a life science environment.
  • Experience managing Quality Systems and/or Compliance in a life science/pharmaceutical environment, including issue management, quality investigations, CAPA management & oversight, quality operations, etc.
  • Sound knowledge of ISO9001, ISO13485, MDSAP, IVDR, 21 CFR 820, 21 CFR 210/211, 21 CFR pt. 11, and additional experience in the biopharmaceutical environment, ICH guidelines, etc., is a plus.
Benefits

As an Agilent employee, you will enjoy a range of benefits, including:

  • Competitive salary and bonus structure.
  • Opportunities for career growth and professional development.
  • A comprehensive benefits package, including health insurance, pension, and life insurance.
  • The chance to work with a talented team of professionals in a dynamic and inclusive work environment.
Travel Requirements

This role includes occasional travel, but no specific end date has been defined. You will have the opportunity to work remotely and collaborate with colleagues across the globe.