Specialist, Quality Assurance - Supplier Quality Management

About the role

We are seeking a seasoned Quality professional to join our global Supplier Quality Management team within a shared services organization supporting Human Health manufacturing sites worldwide. As a Specialist, you will play a critical role in leading and strengthening supplier change management processes, from intake and global triage through impact assessment, change control execution, implementation tracking, and closure. You will work cross-functionally with site and global QA, manufacturing, supply chain, technical operations, procurement , technology teams, and external suppliers to ensure supplier changes are assessed, governed, implemented, and documented in a timely, compliant, and risk-based manner across our global footprint.

Responsibilities

• Works in an empowered, self-directed culture with independent decision-making in the planning, coordinating, and executing SQM activities.
• Lead and support end-to-end supplier change management activities, including supplier change notification intake, global triage, risk and impact assessment, change control initiation, implementation coordination, effectiveness verification, and timely closure.
• Serve as a key process owner or subject matter expert for supplier change management workflows within the supplier quality management system, ensuring consistent execution across sites, functions, and supplier categories.
• Review suppliers change records, supporting documentation, quality agreements, approved supplier list impacts, material/site applicability, and required implementation actions to ensure compliance with procedures and regulatory expectations.
• Perform change-related data queries and reporting to support governance forums, stakeholder decision-making, overdue action follow-up, cycle-time monitoring, and continuous improvement of supplier change management performance.
• Partner with suppliers, procurement, technology, supply chain, manufacturing sites, and global functions to assess supplier change notifications, align implementation requirements, manage change control deliverables, and mitigate supply, quality, and compliance risks.
• Provide guidance to stakeholders on supplier change management requirements, quality data governance, required evidence, procedural expectations, and escalation pathways for complex or high-risk changes.
• Review, disposition, and maintain supplier change records and related supplier master data in the supplier management system, ensuring accuracy, completeness, traceability, and inspection readiness.
• Create and deliver process guidance, procedures, tools, decision trees, training aids, and stakeholder communications to drive consistent supplier change management practices across the global Supplier Quality community.
• Track and trend supplier change management metrics, including volume, cycle time, overdue actions, right-first-time quality, implementation timeliness, data discrepancies, and recurring change themes.
• Support the maintenance of Community of Practice and knowledge management resources for supplier change management by creating or updating process maps, FAQs, templates, procedures, tools, and training content.
• Monitor compliance metrics for suppliers change management processes and drive corrective/preventive actions to improve process adherence, documentation quality , stakeholder accountability, and timely implementation .
• Support internal and external audits/inspections related to supplier change management by preparing evidence, explaining process controls, responding to observations, and coordinating sustainable remediation actions.

Requirements

• 10+ years of experience in the pharmaceutical/biological industry, specializing in Quality Assurance; deep understanding of cGMP, ICH, and relevant regulatory guidelines.
• Preferred
• Hands-on experience with Veeva Vault Quality or equivalent QMS platforms , particularly in supplier change notifications, change control workflows, supplier qualification , approved supplier list management, and supplier performance records .
• Experience managing global supplier change management processes, including administration or coordination of change workflows across multiple sites, functions, systems, and supplier categories.
• Experience interacting with external suppliers/vendors and internal stakeholders to assess, document, escalate, and implement supplier-initiated changes in a regulated environment.
• Proficiency with enterprise quality systems and applications such as SAP.
• Strong analytical, digital visualization, and problem-solving skills with the ability to assess supplier change risk, interpret change trends, identify recurring issues, and translate insights into process improvements .
• Strong Microsoft Office skills - Power BI, Power Apps, PowerPoint, Word, and Excel -with the ability to build change management dashboards, prepare governan

Benefits

Additional Information

Job Description Specialist, Quality Assurance & Operations (Supplier Quality Management) Global Quality Shared Services

Your Match

How well this role fits your profile.

Company Intel

What employees say

Worked at Merck? Share your experience