QMS SUBJECT MATTER EXPERT (SME)

Yokogawa is a leading provider of industrial automation, test and measurement, information systems and industrial services in several industries. 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. Why Join Yokogawa Opportunity to shape the next‑generation digital quality backbone Work at the intersection of QMS, MES, and data‑driven manufacturing Collaborate with global teams across Japan, North America, and Europe Drive innovation in a fast‑growing digital transformation space Yokogawa is an Equal Opportunity Employer. Yokogawa wants a diverse, equitable and inclusive culture. We will actively recruit, develop, and promote people from a variety of backgrounds who differ in terms of experience, knowledge, thinking styles, perspective, cultural background, and socioeconomic status. We will not discriminate based on race, skin color, age, sex, gender identity and expression, sexual orientation, religion, belief, political opinion, nationality, ethnicity, place of origin, disability, family relations or any other circumstances. Yokogawa values differences and enables everyone to belong, contribute, succeed, and demonstrate their full potential. #J-18808-Ljbffr Yokogawa