Associate Director of Enterprise Systems
$200,000–$225,000 year
On-site · Fishers, Indiana, United States
Job Summary
Lead the Enterprise Systems portfolio for a GxP-regulated CDMO, owning strategy and lifecycle management of ERP, CMMS, VMS, MES, and other regulated platforms. Define governance, change control, access management, data integrity, and validation across platforms, maintaining alignment with 21 CFR Part 11, GAMP 5, and EU Annex 11. Drive a multi-year roadmap, ensure regulatory compliance, and oversee CSA/CSV activities. Partner with Manufacturing, Quality, Engineering, Supply Chain, and Finance to define requirements, system designs, and acceptance criteria; manage system integrations, data flows, and security models. Build and lead a cross-functional team of business analysts, systems analysts, project managers, and technical writers; drive standardization, optimization, and automation of core processes in Finance, Controlling, Supply Chain, Manufacturing, Asset Management, and Compliance. Maintain ongoing operations, vendor relationships, and continuous improvement initiatives while ensuring inspection readiness and validated state of regulated enterprise systems. Preferred experience with SAP S/4HANA, Blue Mountain BMRAM, Kneat VMS, and other MES platforms; familiarity with Jira or similar tools; advanced degrees or certifications (SAP, PMP) are a plus.
Required Qualifications
- Bachelor’s degree in Information Technology, Computer Science, Business Administration, Engineering, or a related field
- 12-15+ years of progressive experience managing Enterprise Systems in regulated environments
- Demonstrated experience leading large-scale enterprise system implementations
- Strong understanding of GxP compliance (FDA 21 CFR Part 11, GAMP 5, EU Annex 11)
- Proven ability to lead cross-functional teams and manage multi-workstream programs
- Excellent communication skills with both technical and non-technical stakeholders
Desired Qualifications
- SAP S/4HANA experience
- Blue Mountain BMRAM
- Kneat VMS
- commercial MES platforms
- system integrations, data governance, and reporting/analytics
- Jira or similar PM tools
- pharmaceutical, biotech, medical device, or CDMO manufacturing environments
- Master’s degree, MBA, or relevant certifications (SAP, PMP) a plus
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