Specialist, Quality Assurance - Supplier Quality Management

Job Description

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

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.

What you’ll do

• 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.

What you’ll bring

• 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 governance updates, and communicate clearly across functions, cultures, and time zones.

Proven track record supporting audits and inspections involving supplier change controls, preparing documentation, explaining process governance, and resolving observations effectively and sustainably.

• Detail-oriented, organized, and proactive; able to manage multiple priorities and drive timely, compliant outcomes.

Global or corporate-level experience providing system, process, or business administration support for supplier change management and related QMS activities across an organization.

Why join us

· Impact at scale: Strengthen supplier change management controls across a global network of manufacturing sites and suppliers.

· Professional growth: Deepen your expertise in supplier change controls, global QMS processes, supplier quality systems, and cross-functional governance.

· Continuous improvement: Lead initiatives that improve change cycle times, documentation quality, stakeholder accountability, compliance, and product quality protection.

· Collaborative culture: Partner with suppliers, sites, technology, procurement, supply chain, and quality leaders to deliver timely, compliant supplier change outcomes.

Location and travel

·   Role is based within our global shared services organization based in Pune; flexibility to collaborate across time zones is expected. This is a hybrid role, with 3 days in office per week.

· Occasional travel to manufacturing sites or supplier locations may be required for audits, supplier change alignment discussions, governance workshops, or process harmonization.

Ready to make a global impact? If you’re a quality professional who thrives in complex, multi-site environments and is passionate about strengthening supplier change management, we’d like to hear from you. Submit your profile and let’s build a stronger, more compliant future together.

Required Skills:

Adaptability, Adaptability, Aseptic Manufacturing, Biopharmaceutical Industry, Business Administration, cGMP Compliance, Change Management, Data Analysis, Decision Making, Decision Trees, Detail-Oriented, Documentation Review, FDA Regulations, Interpersonal Relationships, Laboratory Operations, Laboratory Quality Control, Manufacturing, Process Governance, Procurement, Quality Inspections, Quality Operations, Regulatory Compliance, Regulatory Inspections, Stakeholder Communications, Supplier Management {+ 2 more}

Preferred Skills:

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Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

07/2/2026

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