AVP, Quality Management Systems
hace 5 días
Santa Clara
Job Description 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. Key Responsibilities Enterprise QMS Strategy & Governance \n • Define, own, and continuously evolve Agilent's global QMS strategy, ensuring alignment with business objectives, regulatory requirements, and industry best practices.\n, • Serve as the enterprise process owner for core QMS elements, including management controls, document control, training, change control, CAPA, risk management, and data integrity.\n, • Establish global standards, policies, and process models that enable consistent execution across regions, sites, and product lines while allowing appropriate flexibility.\n, • Provide final approval for QMS design decisions, major system changes, and site onboarding readiness.\n, • Ensure the QMS meets applicable global regulations and standards (e.g., ISO 9001/13485, IVDR, FDA QMSR, GMP, ICH, MDSAP, and relevant regional requirements).\n, • Lead the quality system component of regulatory inspections and third-party- audits, ensuring clear accountability, timely responses, and sustainable remediation.\n, • Establish and maintain a risk-based approach to quality system management, embedding risk identification, assessment, and mitigation across processes and lifecycle stages.\n, • Provide enterprise oversight of CAPA effectiveness, ensuring robust root cause analysis, meaningful corrective actions, and performance monitoring.\n, • Lead quality oversight of QMS digitization and data systems, ensuring systems are compliant, validated as required, and enable efficient execution.\n, • Define enterprise expectations for quality data, metrics, and analytics, enabling proactive identification of risks, trends, and improvement opportunities.\n, • Establish and oversee Global Quality's analytics capability related to QMS performance, management review inputs, and continuous improvement.\n, • Own and facilitate Agilent's Quality Management Review (QMR) process, setting expectations for divisional and business-level management reviews.\n, • Define key quality system KPIs and ensure effective reporting to senior leadership, supporting informed decision-making and prioritization.\n, • 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.\n, • Act as a trusted advisor and influencer, enabling quality system adoption and maturity across a complex, matrixed global organization.\n Education • 10+ years of progressive experience in quality systems, quality assurance, or compliance within regulated manufacturing environments.\n, • Demonstrated success designing, standardizing, and scaling global QMS frameworks across multi-site, multi-regulatory organizations.\n, • Experience leading or governing enterprise-wide digital QMS implementations or transformations.\n, • Deep expertise in QMS architecture, governance, and operational execution across GMP and non-GMP environments.\n, • Deep knowledge of ISO 9001, ISO 13485, 21 CFR 210/211, 820, and global regulatory requirements and inspection expectations.\n, • Experience in lean implementation of quality system processes\n, • Experience establishing and maintaining a fit-for-purpose QMS that supports diverse regulatory requirements and accommodates business growth through M&A (mergers and acquisitions)\n, • Proven ability to drive risk-based decision-making, systemic problem solving, and sustainable CAPA.\n, • Executive-level communication and influencing skills, with the ability to translate complexity into clear direction.\n, • Strategic mindset combined with operational rigor and attention to detail.\n, • Ability to lead through influence in a global, matrixed organization.\n\n Additional Details This job has a full time weekly schedule. It includes the option to work remotely. Applications for this job will be accepted until at least March 19, 2026 or until the job is no longer posted. The full-time equivalent pay range for this position is $181,200.00 - $339,750.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: Agilent Technologies, Inc. is an Equal Employment Opportunity and merit-based employer that values individuals of all backgrounds at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to creating and maintaining an inclusive in the workplace where everyone is welcome, and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email [email protected] or contact +1-262-754-5030. For more information about equal employment opportunity protections, please visit . Travel Required: 25% of the Time Shift: Day Duration: No End Date Job Function: Quality/Regulatory