Senior Enterprise Systems Leader for Regulated Manufacturing

incog; Fishers (IN); On-site; USD 180,000 - 240,000; Full time

Job summary

INCOG BioPharma Services in Fishers, IN seeks an Associate Director of Enterprise Systems to own the enterprise platforms and drive end-to-end governance, validation, and lifecycle management for ERP, CMMS, VMS, and MES in a GxP‑regulated environment.

You will lead a cross‑functional applications team, partner with Manufacturing, Quality, and Supply Chain, and ensure compliant, scalable, and integrated systems that support critical operations.

Qualifications

• Bachelor’s degree in IT/CS/Engineering or related field.
• 12–15+ years managing Enterprise Systems in regulated environments.
• Strong GxP compliance knowledge, 21 CFR Part 11, GAMP 5, EU Annex 11.
• Experience leading large enterprise system implementations across ERP/MES/CMMS/VMS.

Responsibilities

• Own enterprise systems portfolio as overall owner and accountability.
• Define governance, data integrity, and lifecycle management standards.
• Lead enterprise application implementations and major enhancements.
• Coordinate cross-functional requirements with Manufacturing, Quality, and Finance.
• Oversee CSA/CSV and validation activities for regulated systems.
• Drive integration, architecture decisions, and end-to-end process alignment.

Skills

Leadership

Regulatory awareness

Cross-functional collaboration

Stakeholder management

Communication skills

Education

Bachelor's degree in IT/CS/Engineering

Tools

SAP S/4HANA

Blue Mountain BMRAM

Kneat VMS

Jira

Job description

INCOG BioPharma Services in Fishers, IN seeks an Associate Director of Enterprise Systems to own the enterprise platforms and drive end-to-end governance, validation, and lifecycle management for ERP, CMMS, VMS, and MES in a GxP‑regulated environment.

You will lead a cross‑functional applications team, partner with Manufacturing, Quality, and Supply Chain, and ensure compliant, scalable, and integrated systems that support critical operations.