Agilent is looking to solve the problem of ensuring robust, compliant, and industry-best-practice product quality and incident management programs across the organization.
Requirements
- 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.
- Strong understanding of Agilent’s markets, products, and customer needs is highly desirable.
- Knowledge of quality management systems
- Experience with regulatory standards
- Experience with quality investigations
Responsibilities
- 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.
Other
- 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.
- Demonstrated success in leading global, cross-functional teams and integrating diverse groups into a cohesive organization.
- Strong business acumen and strategic thinking
- Willingness to travel globally on a regular basis
