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 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, , changes driven by remediation of complex / systemic issues, process transformation, process re-engineering, following M&A, etc.
• 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, in partnership with applicable Business Quality groups, and ensure complex and systemic issues are addressed promptly and sustainably.
• 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 (, Community of Practices, SME networks) 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, , CAPA management, root cause investigation, etc.

Qualifications

Education :

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

Experience :

We Offer :

LI-NE1

Additional Details

This job has a full time weekly schedule. It includes the option to work remotely.Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at : Agilent Technologies Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other protected categories under all applicable laws.

Travel Required

Occasional

Shift

Duration

No End Date

Job Function

Quality / Regulatory