AVP, Supplier Quality

Agilent Technologies•Santa Clara, CA

3d•Remote

About The Position

Role Overview The AVP, Supplier Quality is the enterprise leader accountable for ensuring Agilent’s global supplier quality program fully complies with all applicable global regulatory, statutory, and quality management system requirements across direct materials, indirect materials, services, and external manufacturing partners. This role serves as the enterprise authority for supplier quality governance and regulatory oversight, ensuring that all externally provided materials, components, services, and externally manufactured products consistently meet global regulatory expectations, Agilent QMS requirements, and customer commitments. The AVP establishes and maintains a robust, risk-based‑ supplier quality framework designed to withstand regulatory scrutiny, support inspections, and protect product quality and supply continuity. Operating with an enterprise and growth mindset, the AVP partners closely with Regulatory Affairs, Quality Systems, Supply Chain, Manufacturing, Procurement, and CDMO Quality to ensure supplier quality requirements are clearly defined, consistently implemented, and demonstrably effective across all regions and regulatory jurisdictions. Enterprise Accountability & Regulatory Authority The AVP, Supplier Quality: Owns and governs the global supplier quality program to ensure compliance with all applicable international regulations, standards, and health authority expectations (e.g., ISO standards, global regulatory requirements, GMP where applicable). Acts as the final quality authority for supplier qualification, requalification, auditing, and ongoing oversight across all supplier types, including external manufacturing partners. Defines and enforces regulatory aligned‑ escalation thresholds, investigation rigor, documentation standards, and corrective action requirements for supplier quality issues. Approves supplier selection, corrective action plans, remediation strategies, requalification outcomes, and supplier exit decisions from a regulatory risk perspective. Serves as the primary enterprise interface for regulatory inspections, audits, and inquiries involving suppliers, contract manufacturers, and external service providers. Escalates material supplier quality or compliance risks that could impact regulatory compliance, product approvals, inspections, or market access. Key Responsibilities 1. Global Supplier Quality & Regulatory Governance Define, implement, and continuously improve Agilent’s global supplier quality governance model, ensuring alignment with evolving regulatory requirements across regions. Ensure supplier quality policies, standards, and procedures are fully integrated into the Agilent QMS and consistently applied across GMP and non GMP‑ environments. Establish clear regulatory expectations for suppliers related to: Quality management systems Change control and notification Deviation management and investigations Data integrity and documentation Inspection readiness and regulatory transparency Ensure supplier quality requirements are embedded into supplier selection, contracting, quality agreements, onboarding, and lifecycle management. 2. Supplier Qualification, Performance & Compliance Oversight Own and govern risk-based‑ supplier qualification and requalification processes that meet global regulatory and inspection expectations. Ensure ongoing supplier performance monitoring includes regulatory compliance indicators, audit outcomes, and quality trend analysis. Maintain enterprise level‑ visibility to supplier compliance risks and ensure proactive mitigation before regulatory or customer impact occurs. Provide independent quality and regulatory input to sourcing decisions, dual sourcing ‑strategies, and supplier continuity planning. 3. Supplier Issue Management & Corrective Action Effectiveness Lead or oversee investigations of significant supplier quality or compliance issues with a focus on regulatory impact and root cause. Define expectations for timely, thorough, and regulator-‑ready investigations, including appropriate documentation and evidence. Ensure corrective and preventive actions are effective, sustainable, and verifiable, with clear linkage to regulatory risk reduction. Escalate systemic or unresolved issues that could impact compliance, inspections, product approvals, or customer safety. 4. Supplier Audits, Inspections & External Manufacturing Oversight Establish and execute a global, risk-based‑ supplier audit program aligned with regulatory requirements and health authority expectations. Ensure audit programs adequately cover: Direct and indirect material suppliers Critical service providers External manufacturing and testing partners (CDMOs/CMOs) Provide quality and regulatory oversight of external manufacturing operations, including quality agreements, change management, deviations, and inspection readiness. Support and lead regulatory inspections involving suppliers and external manufacturing partners, ensuring consistent enterprise positioning and responses. 5. Cross Functional‑ Leadership & Regulatory Enablement Partner with Regulatory Affairs, Quality Systems, Supply Chain, Manufacturing, Procurement, and CDMO Quality to ensure aligned regulatory interpretation and execution. Enable scalable, compliant onboarding of new suppliers, materials, and external manufacturing capabilities without compromising regulatory rigor. Serve as a trusted advisor to executive leadership on supplier related‑ regulatory risk, compliance posture, and inspection readiness. Leadership Expectations (Agilent) The AVP, Supplier Quality demonstrates Agilent Leadership Expectations by: Creating clarity and confidence in regulatory expectations across a complex, global supplier network Thinking enterprise first, ensuring regulatory decisions balance business needs with long‑ term‑ compliance and reputation Challenging the status quo to strengthen supplier compliance, audit effectiveness, and inspection readiness Providing visible, decisive leadership during regulatory inspections, supplier crises, and compliance escalations Leading with a growth mindset, continuously improving supplier quality systems in response to regulatory trends Building an inclusive, accountable culture that develops future leaders in supplier quality and regulatory oversight

Requirements

Bachelor's degree in engineering, life sciences, quality, or related technical discipline required; advanced degree preferred
10+ years of progressive experience in supplier quality in regulated manufacturing environments
Demonstrated leadership of global supplier quality programs subject to regulatory oversight
Deep expertise in supplier audits, regulatory inspections, corrective action systems, and compliance risk management
Expertise in root cause analysis, problem solving and applying lean approaches when establishing supplier quality processes and procedures.
Experience in implementation of supplier quality programs that drive proactive engagement of suppliers
Proven ability to lead and influence in global, matrixed organizations
Enterprise level expertise‑ in QMS governance and regulatory compliance
Strong understanding of global regulatory expectations and inspection practices
Proven ability to drive risk ‑based, regulator ‑ready decision making
Executive presence and credibility with regulators, auditors, and senior leadership
Strategic mindset combined with operational discipline and attention to compliance detail

Responsibilities

Define, implement, and continuously improve Agilent’s global supplier quality governance model, ensuring alignment with evolving regulatory requirements across regions.
Ensure supplier quality policies, standards, and procedures are fully integrated into the Agilent QMS and consistently applied across GMP and non GMP‑ environments.
Establish clear regulatory expectations for suppliers related to: Quality management systems Change control and notification Deviation management and investigations Data integrity and documentation Inspection readiness and regulatory transparency
Ensure supplier quality requirements are embedded into supplier selection, contracting, quality agreements, onboarding, and lifecycle management.
Own and govern risk-based‑ supplier qualification and requalification processes that meet global regulatory and inspection expectations.
Ensure ongoing supplier performance monitoring includes regulatory compliance indicators, audit outcomes, and quality trend analysis.
Maintain enterprise level‑ visibility to supplier compliance risks and ensure proactive mitigation before regulatory or customer impact occurs.
Provide independent quality and regulatory input to sourcing decisions, dual sourcing ‑strategies, and supplier continuity planning.
Lead or oversee investigations of significant supplier quality or compliance issues with a focus on regulatory impact and root cause.
Define expectations for timely, thorough, and regulator-‑ready investigations, including appropriate documentation and evidence.
Ensure corrective and preventive actions are effective, sustainable, and verifiable, with clear linkage to regulatory risk reduction.
Escalate systemic or unresolved issues that could impact compliance, inspections, product approvals, or customer safety.
Establish and execute a global, risk-based‑ supplier audit program aligned with regulatory requirements and health authority expectations.
Ensure audit programs adequately cover: Direct and indirect material suppliers Critical service providers External manufacturing and testing partners (CDMOs/CMOs)
Provide quality and regulatory oversight of external manufacturing operations, including quality agreements, change management, deviations, and inspection readiness.
Support and lead regulatory inspections involving suppliers and external manufacturing partners, ensuring consistent enterprise positioning and responses.
Partner with Regulatory Affairs, Quality Systems, Supply Chain, Manufacturing, Procurement, and CDMO Quality to ensure aligned regulatory interpretation and execution.
Enable scalable, compliant onboarding of new suppliers, materials, and external manufacturing capabilities without compromising regulatory rigor.
Serve as a trusted advisor to executive leadership on supplier related‑ regulatory risk, compliance posture, and inspection readiness.