Qms Subject Matter Expert (Sme)

Not just a job but a career

Yokogawa award winner for Best Asset Monitoring Technology and Best Digital Twin Technology at the HP Awards is a leading provider of industrial automation test and measurement information systems and industrial services in several industries.

Our aim is to shape a better future for our planet through supporting the energy transition (bio)technology artificial intelligence industrial cybersecurity etc. We are committed to the United Nations sustainable development goals by utilizing our ability to measure and connect.

About the Team
Our 18000 employees work in over 60 countries with one corporate mission to co-innovate tomorrow. We are looking for dynamic colleagues who share our passion for technology and care for our return we offer you 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.

The QMS Subject Matter Expert (SME) will play a critical role in driving Yokogawas 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

• Bachelors degree in Life Sciences Engineering Quality or related discipline
• Masters 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 drivers 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

Travel: Expected travel up to 30%.

Yokogawa is an Equal Opportunity Employer. Yokogawa wants a diverse equitable and inclusive 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 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.

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