Job Description

NetSuite Consultant - Quality Systems Implementation Position Overview We are seeking a hands-on Netsuite Consultant to lead the configuration, implementation, and validation of quality workflows within NetSuite. This individual will be responsible for delivering a fully functional and validated quality solution within an accelerated three month timeline. The ideal candidate brings deep technical knowledge of NetSuite, extensive software validation experience in a regulated life sciences environment, and the ability to independently drive a complex implementation in partnership with internal stakeholders and external vendors. This is an individual contributor role for someone who can take ownership of the project from initial requirements gathering through final validation and deployment. Key Responsibilities Lead the implementation and validation of quality processes and workflows within NetSuite Translate business and compliance requirements into scalable system configurations, workflows, inspection rules, custom fields, and data structures Configure quality inspection, material traceability, and quality record workflows within the company's ERP environment Own the complete software validation lifecycle, including requirements, risk assessments, validation plans, traceability matrices, test scripts, deviation management, and final validation reports Develop and execute IQ, OQ, PQ, and user acceptance testing activities, as applicable Ensure system configurations and validation documentation comply with applicable GxP requirements, 21 CFR Part 11, and company procedures Partner with Quality, Operations, Supply Chain, Manufacturing, IT, and external implementation vendors to define requirements and resolve technical issues Manage project milestones, dependencies, risks, and deliverables to ensure successful completion within the three month project timeline Create or update procedures, work instructions, training materials, and system administration documentation Support user training, system deployment, and the transition of the validated platform into routine operations Ensure the final solution supports data integrity, product traceability, inspection readiness, and long term scalability What You Will Bring At least five years of direct, hands-on experience designing, implementing, and validating NetSuite workflows within regulated environments Demonstrated success leading software validation projects from requirements gathering through testing, approval, and production release Previous experience within the biotechnology, pharmaceutical, life sciences, or medical device industries Strong technical knowledge of NetSuite architecture, workflows, quality inspection rules, custom fields, system configurations, and underlying data structures Experience with the NetSuite Quality Management System module is highly preferred Working knowledge of GxP requirements, computerized system validation, data integrity principles, and 21 CFR Part 11 Ability to create and execute validation documentation, including validation plans, user requirements, functional specifications, risk assessments, test protocols, traceability matrices, and summary reports Experience collaborating with external implementation partners and holding vendor teams accountable for technical deliverables and project timelines Strong communication skills with the ability to translate technical system requirements for Quality, Operations, and other business stakeholders Ability to operate independently, make informed decisions, and maintain momentum without responsibility for directly managing a team Proven ability to deliver complex system milestones under firm and accelerated deadlines #J-18808-Ljbffr PrecisionPoint

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