Job Description

Senior Specialist, Quality Assurance & Operations (Supplier Quality Management) Global 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 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

· 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.

· Partner closely with Suppliers, Procurement, Technology, Supply Chain management, and sites to support global SQMS intake process, management of the approved supplier list, management of supplier change notifications through change control implementation, SCARs, supplier qualification/ onboarding activities and performance monitoring activities.

· Utilize Veeva and other SQM systems to execute workflows across SQM including direct system entry for management of approved supplier list, supplier change control support, supplier customer advisories, supplier onboarding and supplier performance management activities.

· 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.

· Hands-on experience with Veeva Vault Quality, particularly in supplier qualification/ performance management, management of approved supplier lists, and supplier change management.

· Experience interacting with external entities.

· 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, Power Point, 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.

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:

Adaptability, Adaptability, cGMP Regulations, Change Management, Compliance Assurance, Detail-Oriented, Deviation Management, Good Automated Manufacturing Practice (GAMP), Logistics, Manufacturing, Manufacturing Quality Control, Organizational Performance Management, Pharmaceutical Quality Assurance, Procurement, Product Disposition, Product Lifecycle, Quality Auditing, Quality Management, Quality Management Standards, Quality Standards, Regulatory Compliance, Risk Management, Self Motivation, Strategic Planning, Strategic Procurement {+ 4 more}

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:

03/13/2026

*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.