QMS SUBJECT MATTER EXPERT (SME)

About the role

The QMS Subject Matter Expert (SME) will play a critical role in driving Yokogawa’s OpreX Quality Management System (QMS) solution across Life Sciences, Biopharma, and Food & Beverage industries. This role combines deep domain expertise in quality and compliance with customer-facing responsibilities, including pre-sales support, solution consulting, project execution, and market development.

Key Responsibilities

• QMS Domain Leadership
  Act as the Subject Matter Expert (SME) for Quality Management Systems
  Provide expert guidance on QA/QC processes, compliance frameworks, and digital quality transformation
  Maintain deep working knowledge of GxP regulations (GMP, GLP, GCP), 21 CFR Part 11, EU Annex 11, ICH Q9/Q10, ISO 9001, and ISO 13485 as applicable to regulated industries
  Support internal teams with domain knowledge, training, and best practices

• Pre-Sales & Solution Consulting
  Support sales teams in identifying and qualifying QMS opportunities
  Lead customer workshops, discovery sessions, and requirements gathering
  Define User Requirement Specifications (URS) and ensure solution alignment with customer needs
  Deliver compelling product demonstrations and solution presentations
  Advise customers on Computer System Validation (CSV/CSA) approaches and risk-based validation strategies for eQMS deployments

• Post-Sales & Project Execution
  Provide domain expertise during solution implementation and project execution
  Work closely with delivery teams to ensure compliant and effective solution deployment
  Support validation readiness and ensure alignment with regulatory expectations
  Author and review validation deliverables (Validation Plan, IQ/OQ/PQ protocols, Traceability Matrix, Validation Summary Report) as needed to support customer go-lives

• Business Development & Market Positioning
  Contribute to pipeline development and strategic account growth
  Identify new market opportunities within Life Sciences and adjacent industries
  Support development of value propositions and industry-specific use cases

• Competitive Intelligence & Marketing
  Analyze market trends, competitor offerings, and positioning of QMS vendors
  Define and articulate Yokogawa OpreX QMS differentiation
  Support creation of marketing collateral, thought leadership, and customer success stories

• Product & Solution Improvement
  Provide structured feedback to Product and Engineering teams
  Ensure the QMS platform evolves to meet customer needs and regulatory trends
  Act as the voice of the customer in product roadmap discussions

Requirements

• Bachelor’s degree in Life Sciences, Engineering, Quality, or related discipline
  Master’s degree preferred
• Minimum 5+ years of experience in Quality Management Systems or related roles
  Experience in customer-facing roles (consulting, pre-sales, or solution engineering)
• Strong understanding of validation, audit readiness, and compliance workflows
  Ability to translate business requirements into system configurations
• Hands-on experience with eQMS platforms (e.g., Veeva Vault QMS, MasterControl, TrackWise, ETQ Reliance, ComplianceQuest, or equivalent)
• Familiarity with integration touchpoints between QMS and adjacent systems (MES, LIMS, ERP, DMS)
• A customer-oriented mindset, excellent analytical and problem-solving skills
  Excellent communication and presentation skills
• Ability to work in diverse teams and cross-functionally, prioritize and multitask
  Excellent interpersonal skills and desire to work with customers
• Proficient with Windows operating systems and Microsoft Office

Preferred Qualifications

• Prior experience implementing eQMS solutions in Life Sciences, Biopharma, Medical Device, or Food & Beverage environments
• Certifications such as ASQ CQE, CQA, CMQ/OE, Lean Six Sigma, or RACExposure to digital transformation initiatives connecting Quality, Manufacturing, and Lab systems