Compliance Operation Lead

Job Description

Do you have experience with regulatory requirements for medical devices?

At Agilent, we develop and manufacture reagents, instruments, and software for the in vitro diagnosis of cancer. We are currently seeking a Compliance Operations Lead to join our Global Quality organization. This position will primarily focus on Corrective and Preventive Actions (CAPA) and Inspection Readiness, while also supporting internal and external audit activities across Agilent sites.

In this role, you will be responsible for ensuring compliance with Agilent’s Quality Management System (QMS) and applicable regulatory requirements. You will also lead initiatives to drive continuous process improvement and collaborate with global colleagues to support key business objectives.

You will work cross-functionally with stakeholders across Quality Assurance, Research & Development, Regulatory Affairs, IT, and Marketing. The position reports to the Manager, Compliance Operations, within the Global Quality and Regulatory Affairs (GQRA) organization.

Key Responsibilities:

• Provide quality operations support to Agilent sites and divisions, including CAPA management, inspection/audit readiness, complex/systemic investigations, and remediation activities.

• May serve as the Global Process Owner for CAPA Process

• Promote and maintain compliance with the Agilent QMS and all applicable regulatory standards.

• Act as a Subject Matter Expert (SME) on quality and compliance, leading or supporting complex investigations, driving risk-based decision-making, and fostering continuous improvement.

• Lead or support cross-functional compliance initiatives impacting multiple sites, divisions, or business groups, including remediation efforts, process transformation, and post-M&A integration.

• Support the assessment and continuous improvement of GxP processes and systems.

• Contribute to the identification and management of compliance-related activities across the Business Group.

• Drive CAPA implementation and effectiveness verification in collaboration with Business Quality partners, ensuring timely and sustainable resolution of systemic issues.

• Represent the Compliance function as an SME during external audits and regulatory inspections.

• Participate in and support Communities of Practice and SME networks to enhance organizational capabilities and expertise.

• Contribute to the development and improvement of governance frameworks and compliance-related processes, including root cause analysis and CAPA management.

Qualifications

Education

• Bachelor’s degree in science or a related field is required.

• An advanced degree in engineering, pharmaceutical sciences, or a medical-related discipline is preferred.

Experience

• Minimum of 5 years of experience in the life science industry.

• At least 3 years of direct experience managing Quality Systems and/or Compliance in a regulated life science, pharmaceutical, or medical device environment. This includes experience with issue management, quality investigations, CAPA oversight, and quality operations.

• Solid knowledge of relevant quality and regulatory standards, including ISO 9001, ISO 13485, MDSAP, IVDR, 21 CFR 820, 21 CFR 210/211, and 21 CFR Part 11. Familiarity with biopharmaceutical regulatory frameworks and ICH guidelines is a plus.

• Proven ability to engage with senior leadership and cross-functional teams, demonstrating strong influencing skills and the ability to drive organizational change.

• Excellent collaboration and interpersonal skills.

• Demonstrated ability to manage multiple priorities effectively in a fast-paced environment.

• Experience working in a multidisciplinary, global life science setting.

• Strong written and verbal communication skills.

• Fluency in English, both written and spoken.

What We Offer

• A dynamic, collaborative environment with approximately 40 dedicated QA professionals supporting development, manufacturing, and sustaining activities.

• An exciting opportunity to make a meaningful impact while advancing your career in a world-class company focused on delivering innovative solutions that improve cancer diagnostics globally.

• A supportive, fast-paced, and inclusive workplace culture built on integrity, transparency, and mutual respect.

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Additional Details

This job has a full time weekly schedule. It includes the option to work remotely. Applications for this job will be accepted until at least May 1, 2025 or until the job is no longer posted.

The full-time equivalent pay range for this position is $111,840.00 - $209,700.00/yr plus eligibility for bonus, stock and benefits. 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: https://careers.agilent.com/locations

Agilent Technologies, Inc. is an Equal Employment Opportunity and Affirmative Action employer. We value diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to diversity in the workplace and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email [email protected] or contact +1-262-754-5030. For more information about equal employment opportunity protections, please visit www.agilent.com/en/accessibility.Travel Required: OccasionalShift: DayDuration: No End DateJob Function: Quality/Regulatory