Define and lead the global strategy for product quality and incident management, establishing clear standards and procedures that ensure consistent, high-quality execution across Agilent.
Oversee the Complaint Management Center, ensuring timely, thorough investigations and resolution of product complaints in compliance with regulatory requirements and Agilent standards.
Lead the Vigilance function to ensure prompt assessment of complaints, regulatory reporting where required, and development of Health Hazard Assessments in collaboration with the Office of the Chief Medical Officer.
Ensure Agilent’s quality issue investigation processes are best-in-class, driving root cause analysis and corrective actions that prevent recurrence.
Manage the Critical Quality Issue Notification program, partnering with business quality and regulatory leaders to ensure rapid identification, escalation, and resolution of critical issues.
Direct Agilent’s Field Action process in collaboration with global quality and regulatory partners, ensuring timely and effective resolution of field actions.
Provide actionable product quality metrics and expert analysis to identify trends and enable proactive quality improvements. Collaborate with business leaders to drive data-informed decision-making.
Champion a culture of continuous improvement and operational excellence, fostering a “One Agilent” mindset that enhances collaboration and support across internal and external stakeholders.
Requirements
Bachelor’s degree in Biology, Chemistry, Engineering, or a related Life Sciences discipline; advanced degree preferred.
Minimum 7 years of progressive leadership experience in Quality within a multinational organization, preferably in Diagnostics, Life Sciences, or other highly regulated industries.
Proven expertise in quality investigations for in vitro diagnostics.
Deep knowledge of quality management systems and regulatory standards, including ISO 13485, FDA QSR, IVDD/IVDR, MDD, and related frameworks.
Experience engaging with global regulatory authorities on Field Corrective Actions and Field Safety Corrective Actions.
Demonstrated success in leading global, cross-functional teams and integrating diverse groups into a cohesive organization.
Track record of driving significant process improvements and quality system enhancements.
Strong understanding of Agilent’s markets, products, and customer needs is highly desirable.
Benefits
Health insurance
Retirement plans
Paid time off
Flexible work arrangements
Professional development opportunities
Bonuses
Stock options
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
quality management systemsregulatory standardsISO 13485FDA QSRIVDDIVDRMDDquality investigationsroot cause analysiscorrective actions
Soft skills
leadershipcollaborationcontinuous improvementoperational excellencedata-informed decision-makingcross-functional team leadershipproblem-solvingcommunicationstakeholder engagementtrend analysis