Enterprise Systems Leader for Regulated CDMO Platforms

INCOG BioPharma Services; Fishers (IN); On-site; USD 150,000 - 230,000; Full time

Job summary

INCOG BioPharma Services in Fishers, IN seeks an Associate Director of Enterprise Systems to own the enterprise systems portfolio, govern strategy, and ensure regulatory compliance across ERP, CMMS, VMS, MES and related platforms.

You will lead a cross‑functional team, partner with business units and IT, drive standardization and validation activities, and align technology with manufacturing, quality, and supply chain goals in a GxP environment.

Qualifications

• Bachelor’s degree in Information Technology, Computer Science, Engineering, or related field.
• 12-15+ years of progressive experience managing Enterprise Systems across ERP, MES, CMMS, VMS.
• Demonstrated experience leading large-scale enterprise system implementations in regulated environments.
• Strong understanding of GxP compliance, including FDA 21 CFR Part 11, GAMP 5, and EU Annex 11.

Responsibilities

• Serve as the enterprise owner and single point of accountability for ERP, CMMS, VMS, MES, and other regulated systems.
• Define governance frameworks including change control, access management, and lifecycle management in line with regulatory requirements.
• Own multi-year Enterprise Systems roadmap aligning with growth, manufacturing strategy, and IT objectives.
• Lead enterprise application implementations, milestone tracking, risk management, and executive reporting.
• Oversee CSA and CSV activities for regulated systems ensuring compliant validation and documentation.

Skills

Leadership

Enterprise Systems

Regulatory Compliance

GxP

Project Management

Stakeholder Engagement

Systems Architecture

Data Integrity

CSV/CSA

Regulatory Documentation

Education

Bachelor’s degree in Information Technology, Computer Science, Engineering, or related field

Master’s degree or relevant certifications (SAP, PMP, etc.)

Tools

SAP S/4HANA

Blue Mountain CMMS

Kneat VMS

Rockwell PharmaSuite

Tulip

Job description

INCOG BioPharma Services in Fishers, IN seeks an Associate Director of Enterprise Systems to own the enterprise systems portfolio, govern strategy, and ensure regulatory compliance across ERP, CMMS, VMS, MES and related platforms.

You will lead a cross‑functional team, partner with business units and IT, drive standardization and validation activities, and align technology with manufacturing, quality, and supply chain goals in a GxP environment.