QMS Subject Matter Expert (SME)

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.

The SME will collaborate cross-functionally with Sales, Product Development, and Delivery teams to ensure the QMS solution aligns with evolving regulatory requirements and market expectations, while actively supporting business growth.

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 Support

• 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 Support

• 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)
• Working knowledge of core QMS processes: Deviations/Nonconformance, CAPA, Change Control, Document Management, Training Management, Audit Management, Complaints, and Supplier Quality

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
• Experience working in cross-functional and global teams
• Self-motivation and the desire to work with customers
• Excellent oral and written communication 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
• Valid driver’s license and ability to travel domestically and internationally as required

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 RAC
• Exposure to digital transformation initiatives connecting Quality, Manufacturing, and Lab systems

Work Environment & Travel

• Combination of office, remote, and customer site engagement
• Travel required (20 ~ 30%) depending on projects and customer needs
• Yokogawa being global company, working outside of regular business hours may be required.

Travel: Expected travel up to 30%.