eQMS Technical Manager
Scientific Protein Laboratories
Summary
The eQMS Technical Manager will be integrated into the Quality Assurance organization and will support all core Quality System functions through the administration, configuration, validation, and continuous improvement of the electronic Quality Management System (eQMS), including Electronic Batch Records (EBRs).
Job description
The individual is expected to possess prior experience in a regulated cGMP environment and demonstrate the ability to rapidly achieve independent operational capability. With appropriate onboarding and management guidance, the Technical Manager is expected to quickly assume full ownership of assigned eQMS and EBR responsibilities and provide reliable, compliant quality system support across the organization.
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.
Requirements
- Associate degree or equivalent work experience required
- System administration of an electronic quality management system experience required
- Bachelor's degree preferred
- 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
Benefits
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- AD&D Insurance
- Short-Term Disability Insurance
- Long-Term Disability Insurance
- Health Savings Account
- Flexible Spending Account
- Employee Assistance Program
- Paid Vacation
- Paid Holidays
- 401(k)
- Advancement Opportunities
- Team-Oriented Environment
- Community Involvement
- Company Events
Company overview
Scientific Protein Laboratories (SPL) is a leading global supplier of high-quality active pharmaceutical ingredients (APIs) with over four decades of experience in the pharmaceutical manufacturing industry. Founded in 1976 in Waunakee, Wisconsin, the company specializes in cGMP biopharmaceutical manufacturing and is among the largest commercial suppliers of Heparin Sodium USP, Pancreatin USP, and Pancrelipase USP. SPL serves pharmaceutical, veterinary, and food industries worldwide, operating manufacturing facilities in both Waunakee, Wisconsin and Sioux City, Iowa. The company focuses on extracting, isolating, and purifying naturally-derived materials from animal and plant sources, with particular expertise in porcine-sourced starting materials. As a subsidiary of Shenzhen Hepalink Pharmaceutical since 2014, SPL maintains a strong commitment to regulatory compliance and quality assurance, operating strictly in accordance with FDA's cGMP requirements while providing comprehensive regulatory support to its global customer base.