Roles/Responsibilities:
- Serve as a Quality SME for SAP QM and Digital Quality solutions, translating GMP business needs into system requirements and process improvements
- Support SAP QM incident management, sustainment, and solution releases
- Drive standardization and optimization of quality processes (e.g., material status, usage decision, jurisdictional control)
- Partner cross-functionally with Quality, Manufacturing, Supply Chain, and IT
- Support global deployments through testing, change management, documentation, and training
- Contribute to continuous improvement and KPI-based performance monitoring
- Perform activities to ensure compliance with applicable regulatory requirements
- Participate in developing Standard Operating Procedures to ensure quality objectives are met
- May facilitate external audits/inspections as SAP SME and support corrective actions
- May assist with compliance audits as required
Basic Qualifications:
- 6+ years relevant experience in a GMP environment related field and a BS/BA (computer science)
- 4+ years relevant experience and an MS
- Prior experience in pharmaceutical or biopharmaceutical industry
- Strong GMP and Quality Systems knowledge
- Familiarity with MES, LIMS (or GLIMS), and document management systems
- Strong verbal, technical writing, and interpersonal skills
- Proficiency in Microsoft Office applications
- SAP system development, coding and/or validation
- Hands-on experience in backend development and coding practices
Benefits (explicitly stated): Company-sponsored medical, dental, vision, and life insurance plans; eligible employees may participate in benefit plans.
Application instruction (explicitly stated): Apply via the Internal Career Opportunities portal in Workday.