AVP, Quality Management Systems

Agilent Technologies•Santa Clara, CA

3d•Remote

About The Position

Role Overview The Associate Vice President, Quality Management Systems (QMS) is the enterprise leader accountable for the strategy, design, governance, and continuous improvement of Agilent’s global Quality Management System. This role ensures the QMS is fit-for-purpose, scalable, risk-based, and compliant across a diverse portfolio of regulated and non-regulated products, manufacturing sites, suppliers, and external partners. The AVP serves as the global authority on quality system architecture, driving standardization while enabling business agility. They translate Global Quality strategy and regulatory expectations into robust, digital-enabled systems and processes that support right-first ‑-‑time execution, inspection readiness, and sustainable compliance. The role is a key advisor to Global Quality leadership and enterprise stakeholders on systemic quality risks, maturity, and performance.

Requirements

Bachelor’s degree in engineering, Life Sciences, Quality, or a related technical discipline required; advanced degree preferred.
10+ years of progressive experience in quality systems, quality assurance, or compliance within regulated manufacturing environments.
Demonstrated success designing, standardizing, and scaling global QMS frameworks across multi-site, multi-regulatory organizations.
Experience leading or governing enterprise-wide digital QMS implementations or transformations.
Direct experience supporting regulatory inspections and audits at a system level.
Deep expertise in QMS architecture, governance, and operational execution across GMP and non-GMP environments.
Deep knowledge of ISO 9001, ISO 13485, 21 CFR 210/211, 820, and global regulatory requirements and inspection expectations.
Experience in lean implementation of quality system processes
Experience establishing and maintaining a fit-for-purpose QMS that supports diverse regulatory requirements and accommodates business growth through M&A (mergers and acquisitions)
Proven ability to drive risk-based decision-making, systemic problem solving, and sustainable CAPA.
Executive-level communication and influencing skills, with the ability to translate complexity into clear direction.
Strategic mindset combined with operational rigor and attention to detail.
Ability to lead through influence in a global, matrixed organization.

Responsibilities

Enterprise QMS Strategy & Governance Define, own, and continuously evolve Agilent’s global QMS strategy, ensuring alignment with business objectives, regulatory requirements, and industry best practices.
Serve as the enterprise process owner for core QMS elements, including management controls, document control, training, change control, CAPA, risk management, and data integrity.
Establish global standards, policies, and process models that enable consistent execution across regions, sites, and product lines while allowing appropriate flexibility.
Provide final approval for QMS design decisions, major system changes, and site onboarding readiness.
Integrates new M&A (mergers and acquisitions) into Agilent’s quality management system as defined in the M&A integration plans.
Regulatory Compliance & Inspection Readiness Ensure the QMS meets applicable global regulations and standards (e.g., ISO 9001/13485, IVDR, FDA QMSR, GMP, ICH, MDSAP, and relevant regional requirements).
Lead the quality system component of regulatory inspections and third-party‑ audits, ensuring clear accountability, timely responses, and sustainable remediation.
Proactively monitor emerging regulations and inspection trends, driving anticipatory updates to QMS frameworks and processes.
Risk Management & CAPA Oversight Establish and maintain a risk-based approach to quality system management, embedding risk identification, assessment, and mitigation across processes and lifecycle stages.
Provide enterprise oversight of CAPA effectiveness, ensuring robust root cause analysis, meaningful corrective actions, and performance monitoring.
Escalate systemic quality risks and trends to Global Quality leadership with data-driven‑ insights and recommended actions.
Digital QMS & Data Analytics Lead quality oversight of QMS digitization and data systems, ensuring systems are compliant, validated as required, and enable efficient execution.
Define enterprise expectations for quality data, metrics, and analytics, enabling proactive identification of risks, trends, and improvement opportunities.
Establish and oversee Global Quality’s analytics capability related to QMS performance, management review inputs, and continuous improvement.
Provide Computer Systems Validation oversight to technology solutions supporting end-to-end processes in Agilent.
Management Review & Performance Monitoring Own and facilitate Agilent’s Quality Management Review (QMR) process, setting expectations for divisional and business-level management reviews.
Define key quality system KPIs and ensure effective reporting to senior leadership, supporting informed decision-making and prioritization.
Drive accountability for action closure and effectiveness following management reviews.
Enterprise Collaboration & Influence Partner closely with Manufacturing, Supply Chain, MSAT (Manufacturing Science & Technology), Regulatory, R&D, IT, and Quality Assurance teams to embed QMS requirements across the product and process lifecycle.
Act as a trusted advisor and influencer, enabling quality system adoption and maturity across a complex, matrixed global organization.
Build and sustain a culture of quality ownership, prevention, and continuous improvement.