Qms Subject Matter Expert (Sme)

Yokogawa • Sugar Land, TX

7d • Hybrid

About The Position

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.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, Quality, or related discipline
• 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

Nice To Haves

• Master’s degree preferred
• 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

Responsibilities

• 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
• 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
• 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
• 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
• 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
• 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

Benefits

• Great career opportunities to grow yourself in a truly global culture where respect, value creation, collaboration, integrity, and gratitude are highly valued and exhibited in everything we do.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior