Associate Director of Enterprise Systems

The Associate Director of Enterprise Systems serves as the enterprise system and process owner for a portfolio of mission‑critical Enterprise Systems within a GxP‑regulated Contract Development and Manufacturing Organization (CDMO). This role has end‑to‑end accountability for the strategy, governance, delivery, and lifecycle management of multiple enterprise platforms, including but not limited to:

• ERP (e.g., SAP ByDesign, S/4
  
  HANA, Microsoft Dynamics, Oracle Net Suite)
• CMMS (e.g., Blue Mountain)
• VMS (e.g., Kneat)
• MES (e.g. Rockwell Pharma Suite, Apprentice, Tulip)
• Other regulated enterprise systems supporting Manufacturing, Quality, Engineering, Supply Chain, and Finance

The Associate Director of Enterprise Systems ensures these systems collectively enable compliant, scalable, and efficient operations
, while maintaining data integrity, system validation, and alignment with business strategy and regulatory expectations.

This leader oversees a cross‑functional applications team
, acts as a primary liaison between business stakeholders, IT leadership, and external partners, and drives standardization, integration, and continuous improvement across the enterprise application landscape.

• Serve as the overall enterprise owner and single point of accountability for the organization’s Enterprise Systems portfolio, including ERP, CMMS, VMS, MES, and other regulated systems.
• Define and maintain application governance frameworks including change control, access management, system ownership, periodic reviews, and lifecycle management in alignment with 21 CFR Part 11, GAMP 5, and EU Annex 11
  .
• Establish and enforce standards for data integrity, master data management, configuration management, and system documentation across all enterprise platforms.
• Own and maintain a multi‑year Enterprise Systems roadmap
  , ensuring alignment with organizational growth, manufacturing strategy, regulatory requirements, and IT objectives.
• This role does not include ownership of the Quality Management System (QMS, Veeva Vault) or QC Laboratory Systems, which are managed under separate functional ownership outside of IT Enterprise Systems.

• Lead and oversee enterprise application implementations and major enhancements
  , including ERP, CMMS, VMS, and MES initiatives.
• Direct project planning, resource allocation, milestone tracking, risk management, and executive reporting across multiple concurrent application programs.
• Partner with functional leaders across Manufacturing, Quality, Engineering, Supply Chain, Finance, Technical Services, and Warehouse Operations to define business requirements, system designs, and acceptance criteria.
• Manage relationships with system integrators, software vendors, and third‑party service providers
  , ensuring delivery quality, regulatory compliance, and adherence to scope and timelines.
• Oversee Computer System Assurance (CSA) and
  Computer System Validation (CSV) activities for all regulated Enterprise Systems, ensuring compliant implementation, documentation, and ongoing validated state.

• Own key decisions related to enterprise application architecture
  , integrations, data flows, and security models.
• Coordinate design, testing, and support of integrations between ERP, MES, CMMS, VMS, LIMS, WMS, and other connected systems.
• Ensure Enterprise Systems operate as a cohesive, integrated ecosystem supporting end‑to‑end business processes.

• Act as process owner or co‑owner for core enterprise business processes spanning:
• Finance and Controlling
• Supply Chain and Procurement
• Manufacturing and MES execution
• Asset Management and Maintenance (CMMS)
• Validation and Quality documentation (VMS)
• Drive process standardization, optimization, and automation across systems.
• Ensure processes are documented, controlled, and continuously improved post‑go‑live.
• Partner with Quality and Regulatory Affairs to ensure system-supported processes remain inspection‑ready and compliant with applicable regulations.

• Build, lead, and develop a high‑performing enterprise systems…