Compliance Operation Lead

Compliance Operation Lead

Apply locations Denmark-Glostrup. Option to Work Remote in Germany.

Job Description

Are you experienced with regulatory requirements for medical devices?

At Agilent, we develop and produce reagents, instruments, and software for in vitro diagnostic of cancer, and we are currently looking for a Compliance Operation Lead to work primarily in Corrective and Preventive Action as well as in Inspection Readiness projects but also to support internal and external audits activities for our Agilent sites. This is a Global Agilent Quality position.

In this role, you will be responsible for supporting compliance with Agilent’s QMS and external requirements. You will also be responsible for driving initiatives to ensure continuous improvements of our processes as well as collaborating with international colleagues to achieve company goals.

You will partner with many stakeholders across the organization, covering but not limited to QA, R&D, RA, IT, and Marketing.

You will report to the Manager, Compliance Operations, GQRA organization.

• Support Agilent sites/divisions with a broad spectrum of Quality Operations support (CAPA, inspection/audit readiness, complex/systemic investigations, remediation).
• Serve Agilent as Global Process Owner for Nonconformity Management.
• Support Agilent sites/divisions by adhering to the Agilent QMS and applicable regulatory requirements and standards and promote overall compliance posture.
• 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.
• Support and/or lead cross-functional strategic projects in the compliance space, with impact on sites, divisions, or an entire business group.
• Lead/support the assessment and update of relevant GxP processes and systems as required.
• Support the identification, maintenance, and management of compliance activities across a Business Group within Agilent to promote a state of compliance.
• Drive CAPA and effectiveness check requirements and improvements.
• Partner with Business Quality representatives to develop and implement corrective and preventive actions based on trends and identification of systemic issues.
• Represent QCS/Compliance as a compliance SME during external audits and Health Authority inspections as required.
• Support relevant processes and fora that help drive upskilling and capability building across the organization.
• Support the continual improvement of processes and governance components supporting relevant compliance processes in scope.

Qualifications

Education:

Bachelor’s degree in science or a related field is required; advanced degree in engineering, pharmaceutical, or medical field preferred.

Experience:

• 5+ years of industry experience in a life science environment.
• Experience must include 3+ years of 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, 21 CFR pt. 11.
• Demonstrated ability to interface with senior leaders and cross-functional teams.
• Strong collaborative skills.
• Demonstrated ability to effectively manage multiple priorities with a sense of urgency.
• Experience in operating in a multi-disciplinary life science environment.
• Excellent written and verbal communication skills.
• Fluency in written and spoken English.

We Offer:

• An inspiring and social environment with around 40 skilled colleagues in the QA department.
• A great opportunity to make a significant impact and develop your skills in a world-class company.
• A role among passionate colleagues, in a growth-oriented and inclusive environment.
• Agilent offers core global benefits to all staff.

Travel Required

Occasional

Shift

Day

Duration

No End Date

Job Function

Quality/Regulatory

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