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 Senior Specialist, you will play a critical role in strengthening quality processes across supplier quality, including our supplier quality management system (SQMS), global data management, supplier qualification activities, and supplier quality performance management. You will work cross-functionally with site and global QA, manufacturing, supply chain, technical operations, procurement and our external entities to ensure robust compliance, operational excellence, and continual improvement 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.
• Support end-to-end quality operations across SQM, including SQMS global data management, supplier change management- from global triage to implementation of supplier change controls, supplier qualification, and performance management activities.
• Primarily responsible for supporting data quality governance and day-to-day support for the supplier management system.
• Review data entered by system users, perform data quality approvals, enforce and audit data for compliance with system and procedure requirements, and work with system users to address any identified data discrepancies.
• Perform data queries/ reports to meet customer needs and assist in system procedural updates, user training, and enhancements.
• Partner with Suppliers, Procurement, Technology, Supply Chain, sites, and global functions to support SQMS, manage approved suppliers, handle change notifications via change control, SCARs, supplier qualification/onboarding, and monitor performance.
• Proactively support and provide guidance relative to Quality Data Governance within Supplier Quality or Supplier Domain.
• Review and appropriately disposition data and records in the supplier management system.
• Routinely support creating and presenting business processes, procedures, tools, and training aids to large groups.
• Track and trend supplier master data quality elements and support visibility presentations to applicable sites/global functions.
• Support the maintenance of the Community of Practice, and/or Knowledge network SharePoint across the Supplier Quality community related to assigned areas by creating or updating processes, procedures, tools, etc.
• Monitor compliance metrics for SQM processes (e.g., cycle times, on-time completion, RFT, data discrepancies, etc.) and drive corrective/preventive actions to improve quality performance.
• Support internal and external regulatory audits/inspections—preparing evidence, responding to observations, and coordinating remediation actions that meet global standards.

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, particularly in supplier qualification/ performance management, management of approved supplier lists, and supplier change management.
• Experience with managing a global system (administration of a global system or coordination of use)
• Experience interacting with external entities or suppliers/vendors.
• Proficiency with enterprise quality systems and applications such as SAP.
• Strong analytical, digital visualization, and problem-solving skills with the ability to assess risk, visualize and interpret data trends, and translate insights into action.
• Strong Microsoft Office skills- Power BI, Power Apps, PowerPoint, Word, and Excel. Excellent collaboration and communication skills; adept at working across functions, cultures, and time zones in a global organization.
• Proven track record supporting audits and inspections, preparing documentation, 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/business administration support of QMS-related activities across an organization.

Why join us

· Impact at scale: Influence quality excellence across a global network of manufacturing sites and suppliers.

· Professional growth: Work with diverse teams and systems, deepening your expertise in Supplier Quality Management.

· Continuous improvement: Lead initiatives that strengthen compliance, streamline processes, and improve product quality.

· Collaborative culture: Partner with various functional experts across supplier base, sites, technology, procurement, and supply chain to deliver reliable, compliant results.

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, alignment workshops, or process harmonization.

Ready to make a global impact? If you’re a quality leader who thrives in complex, multi-site environments and loves optimizing QMS processes, we’d like to hear from you. Submit your profile and let’s build a stronger, more compliant future together.

Required Skills:

Aseptic Manufacturing, Audits Compliance, Corrective and Preventive Action (CAPA), Detail-Oriented, Documentation Review, Driving Continuous Improvement, GMP Compliance, Quality Assurance Tools, Quality Auditing, Quality Management Systems (QMS), Quality Standards, Root Cause Analysis (RCA), Supplier Quality Management, Troubleshooting

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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:

07/8/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.