Vice President, Global Quality Systems and Compliance
5301 Stevens Creek Blvd
Santa Clara, CA 95051
Agilent inspires and supports discoveries that advance quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek -- so they can do what they do best: improve the world around us. Information about Agilent is available at www.agilent.com.
Reporting to the Senior Vice President of Global Quality and Regulatory Affairs (GQRA), the Vice President of Global Quality Systems and Compliance will be responsible for setting strategy and leading the Global Quality Systems and Compliance organization for Agilent. S/he will have oversight for ensuring that Agilent’s Quality Management System is robust and in alignment ISO requirements and applicable regulatory requirements, and will establish and maintain governance processes for quality improvement across Agilent.
S/he will be a key member of the GQRA executive leadership team and will work in close partnership with the GQRA leaders to refine and execute the multi-year GQRA strategic roadmap.
- Establish the One Agilent Global Quality Management System (QMS) with sufficient flexibility to support a diverse product portfolio. Ensure that the QMS is robust, complies with applicable regulatory requirements, and establishes global standards and procedures that set clear expectations for Agilent’s businesses.
- Develop a Knowledge management function that will set training requirements for Agilent functions engaged in GxP-regulated or ISO compliant processes. Provide training development and training matrices support.
- Establish and lead all aspects of GQRA’s risk management and analytics function, ensuring that a sound risk management methodology is applied to Agilent products and processes, and that data analytics are utilized to find opportunities for product and process improvement.
- Enhance and facilitate Agilent’s Executive Quality Management Review (EQMR) and set expectations for Division and Business level Management Reviews. Ensure that subordinate management reviews link to EQMR.
- Provide oversight of CAPA resolution across Agilent, with robust process development and metrics to track CAPA performance.
- Lead Agilent’s Inspection readiness program, with tools, training, and project management of inspection readiness initiatives in partnership with the Business Quality and Regulatory Affairs organizations.
- Conduct Agilent’s Internal audit program, using a risk-based approach to develop a robust audit schedule. Ensure capability to audit against multiple, diverse requirements including ISO, MDSAP, IVDR, and GxP.
- Lead the Agilent Notified body certification process, maintaining a schedule of all certification expirations, schedule of certification audits, and interacting directly with notified bodies to promote consistent communication. Ensure that any findings from notified body audits are quickly resolved, and that takeaways from these audits are shared across Agilent.
- Lead Computer System Quality Assurance and provide quality oversight of digitization initiatives.
- Develop and lead Supplier quality oversight function in close partnership with Business functions and Procurement. Ensure the qualification and ongoing assessment of supplier quality performance.
- Supervise Associate Vice President and/or Director level heads of Internal Audits, Risk Management and Analytics, Knowledge Management, Computerized Systems Quality Assurance, and Inspection/Notified Body Audit Preparation and Management.
- Strive for operational excellence and facilitate the One Agilent culture and mindset enabling outstanding support for internal and external business partners
- Minimum Bachelor's Degree in Biology, Chemistry, Engineering or Life Sciences discipline. Advanced degree a plus.
- Demonstrated industry experience in Diagnostics, Life Sciences and/or highly regulated markets.
- Minimum of (10+) years of Quality leadership roles, of progressive managerial experience, in a multi-national company.
- Adept knowledge of quality management systems and Quality System Standards, including but not limited to ISO quality standards, medical device regulations (ISO 13485, FDA QSR, IVDD, MDD etc.) and related standards.
- Extensive experience hosting regulatory inspections and interacting with regulators.
- Outstanding leadership and team building skills, ideally having integrated diverse global teams into a united organization sharing a common vision and mission.
- Experience driving significant process improvement efforts, leveraging Lean 6-Sigma concepts and methodologies.
- The ideal candidate will have deep familiarity with the markets that Agilent serves. products and customers' business needs.
Things that will make you stand out
- Excellent business acumen
- Visionary thinker with a desire to excel and inspire others
- Self-reliant, passionate, enthusiastic with focus on driving results
- Demonstrated ability to act as change agent
- Strong communicator
- Confident personality
- Excellent influencing and facilitation skills
- Perseverance in face of resistance
- Structured and well organized
- Willing to travel globally on a regular basis