eQMS Technical Manager

Scientific Protein Laboratories•Waunakee, WI

1d•Onsite

About The Position

Scientific Protein Laboratories (SPL) is seeking an eQMS Technical Manager to join their Quality Assurance organization. This role will support core Quality System functions by administering, configuring, validating, and continuously improving the electronic Quality Management System (eQMS) and Electronic Batch Records (EBRs). The ideal candidate will have prior experience in a regulated cGMP environment and be able to quickly become proficient in managing eQMS and EBR responsibilities, providing compliant quality system support across the organization.

Requirements

Associate degree or equivalent work experience required
System administration of an electronic quality management system experience
History of providing reliable eQMS systems for a regulated cGMP organization aligned with ALCOA+ principles
Experience ensuring data integrity
Experience configuring, maintaining and supporting eQMS Modules
Experience designing and maintaining electronic workflows, approval routing, access
Supported creation, configuration validation, release and maintenance of EBR’s (Electronic Batch Records)
History of partnership with Manufacturing, IT to ensure EBR’s are aligned all approvals and records, processes and regulatory expectations
Create and optimize dashboards and reports using eQMS analytics
Support end user training
Participate in internal audits, regulatory inspections and customer audits
Prepare audit documentation, respond to inquiries and lead remediation of system-related findings

Nice To Haves

Bachelor’s degree
System administration of an electronic quality management system experience

Responsibilities

Configure, maintain, and support eQMS modules, including Document Control, Change Management, Training, Audit Management, Quality Events (Deviations, CAPA, Complaints), and Electronic Batch Records (EBRs).
Design and maintain compliant electronic workflows, approval routing, and controlled access based on defined roles and responsibilities.
Ensure data integrity, traceability, and lifecycle management of records in alignment with ALCOA+ principles.
Support creation, configuration, validation, release, and maintenance of Electronic Batch Records.
Partner with Manufacturing, Quality, and IT to ensure EBRs are aligned with approved master batch records, process requirements, and regulatory expectations.
Support EBR review processes, exception handling, and batch release activities.
Develop and support system integrations and data exchanges using the eQMS API toolkit and related interfaces.
Ensure secure data transfer, version control, and audit trail functionality across integrated systems.
Develop, maintain, and optimize dashboards and reports using eQMS analytics and insights tools.
Support business process monitoring, trending, and management review through meaningful quality metrics.
Maintain access controls and user role management (Author, Reviewer, Approver, Viewer) in compliance with segregation-of-duties principles.
Execute computer system validation (CSV) and periodic review activities in accordance with internal procedures and regulatory requirements.
Support eQMS and EBR release cycles using validation accelerators and risk-based validation approaches.
Ensure ongoing compliance with 21 CFR Part 11, EU Annex 11, data integrity, and applicable global regulatory expectations.
Serve as primary point of contact for system troubleshooting, issue investigation, and root cause analysis related to eQMS and EBR functionality.
Coordinate corrective and preventive actions for system-related deviations or audit observations.
Support end-user training, onboarding, and change management initiatives.
Develop training materials, user guides, and knowledge articles to promote consistent and compliant system use.
Support global rollout, adoption, and continuous improvement of eQMS solutions.
Actively participate in internal audits, regulatory inspections, and customer audits related to quality systems, computerized systems, and EBRs.
Prepare audit documentation, respond to audit inquiries, and lead remediation of system-related findings.