Business Process SME SQM & QRM (Veeva Quality / Merck Process)

Overview

Remote
Accepts corp to corp applications
Contract - W2
Contract - Independent
Contract - 13 day((s))

Skills

Business Process SME
Veeva QMS
SQM
QRM

Job Details

Job Title: Business Process SME SQM & QRM (Veeva Quality / Merck Process)

Position Summary

We are seeking experienced Business Process Subject Matter Experts (SMEs) with deep knowledge of Supplier Quality Management (SQM) and Quality Risk Management (QRM) processes in a regulated, pharmaceutical environment. The SME(s) will play a key role in defining, harmonizing, and optimizing global business processes aligned with Merck's quality standards and supporting the implementation of Veeva Quality applications (Vault QMS, QualityDocs, etc.).

The ideal candidates will bring a combination of process expertise, Veeva system knowledge, and regulated industry experience, ensuring that process design and configuration align with compliance, business, and digital transformation objectives.

Key Responsibilities

  • Serve as the primary process expert for SQM (Supplier Qualification, Audits, Performance Management) and/or QRM (Risk Identification, Assessment, Mitigation, and Review) within the global quality transformation program.
  • Collaborate with business stakeholders, IT teams, and Veeva implementation partners to define and document to-be process designs and functional requirements.
  • Translate Merck's global process standards and policies into system workflows and configurations within Veeva Quality applications.
  • Participate in fit-gap analysis, ensuring business needs align with Veeva standard functionality and identifying appropriate enhancements or workarounds.
  • Support user story creation, UAT, and training activities by ensuring business requirements are accurately represented and validated.
  • Provide expert input into the development of SOPs, work instructions, and process documentation.
  • Ensure process alignment with GxP, ICH Q9, ICH Q10, and other applicable regulatory and quality system requirements.
  • Partner with cross-functional SMEs (e.g., Deviation, CAPA, Change Control, Audit) to ensure integrated quality processes across the Veeva platform.
  • Act as a liaison between business users, IT, and implementation partners to ensure successful design, adoption, and continuous improvement.

Qualifications

Required:

  • Bachelor's degree in Life Sciences, Engineering, or related discipline.
  • 5+ years of experience in pharmaceutical or biotech quality systems, with a focus on Supplier Quality Management and/or Quality Risk Management.
  • Proven knowledge of Merck's global quality processes, procedures, and governance (preferred for contractors familiar with internal frameworks).
  • Hands-on experience with Veeva Vault Quality Suite (e.g., QMS, QualityDocs, Training).
  • Deep understanding of GxP regulations, ICH Q9 (Risk Management), and ICH Q10 (Pharmaceutical Quality System).
  • Strong communication and facilitation skills to engage cross-functional global teams.
  • Experience participating in or leading process design workshops, system testing, and validation in a regulated environment.

Preferred:

  • Prior participation in a global Veeva implementation or rollout within a regulated organization.
  • Experience in Merck or similar large pharma process frameworks.
  • Familiarity with supplier qualification systems, audit management, and risk assessment tools.
  • Lean Six Sigma, Quality Auditor, or Quality Risk Management certification.

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