IT Program Manager – Pharma Ops & GxP Systems

Augustbioservices; Nashville (TN); On-site; USD 130,000 - 170,000; Full time

Job summary

August Bioservices is seeking an IT Project Manager in Nashville to lead enterprise IT initiatives across ERP, LIMS, Data Historian, MES/eBR, and other systems. You will coordinate IT, Engineering, Manufacturing, Quality, Validation, and external partners to ensure on-time, within-budget delivery that meets regulatory expectations.

The ideal candidate has 5+ years in IT/digital transformation projects, especially in pharmaceutical or CDMO environments, with strong stakeholder and vendor

Qualifications

• Bachelor’s degree in information technology, Computer Science, Engineering, Business Administration, Project Management, or a related discipline.
• 5+ years of progressive experience in IT, digital transformation, enterprise application, manufacturing technology, or engineering technology projects.
• Experience managing manufacturing and engineering technology projects involving SCADA, Data Historian, MES, BMS, EMS, or automation systems.
• Experience managing projects within pharmaceutical, biotechnology, medical device, CDMO, or another regulated life sciences environment strongly preferred.
• Ability to translate technical concepts into business focused outcomes and leading teams, influencing decision and driving accountability across the key stakeholders.
• Strong project management, planning, organization, and prioritization skills.
• Ability to manage multiple complex and cross-functional projects simultaneously.
• Strong understanding of technology project lifecycles and project governance.
• Understanding of IT/OT environments and the coordination required between IT, Engineering, Automation, Manufacturing, and cybersecurity teams.
• Working knowledge of GxP, 21 CFR Part 11, data integrity, CSV, and CSA principles.
• Strong stakeholder and vendor management skills.
• Ability to facilitate cross-functional discussions and drive teams toward decisions and deliverables.
• Strong risk, issue, dependency, and change-management capabilities.
• Ability to communicate technical project information clearly to both technical and non-technical stakeholders.
• Excellent written, verbal, presentation, and executive communication skills.
• Ability to manage competing priorities while maintaining focus on project objectives and business outcomes.

Responsibilities

• Lead end-to-end project management for ERP, LIMS, Data Historian, MES/eBR and other enterprise IT systems initiatives from planning and requirements gathering through deployment and post implementation support framework.
• Build and maintain project charters, project plans, schedules, milestones, budgets, resource plans, RAID logs, decision logs, and project status reports.
• Coordinate activities across IT, Engineering, Automation, Manufacturing, Quality, Validation, Laboratory Operations, Supply Chain, Finance, and other business functions.
• Develop and maintain detailed project plans , status reports, KPIs and executive dashboards.
• Work with business and technical SMEs to ensure project requirements, scope, deliverables, responsibilities, and success criteria are clearly defined.
• Track project schedules, dependencies, milestones, deliverables, and resource commitments to ensure timely completion.
• Identify project risks, issues, constraints, and dependencies and drive appropriate mitigation, escalation, and resolution.
• Manage and coordinate third-party vendors, software providers, consultants, engineering firms, and system integrators.
• Monitor vendor performance against agreed scope, schedule, deliverables, and contractual commitments.
• Partner with Quality and Validation teams to coordinate Computer System Validation (CSV) and Computer Software Assurance (CSA) activities for GxP-regulated systems.
• Ensure required project and validation documentation is completed in accordance with applicable procedures and regulatory expectations.
• Support prioritization and resource planning across multiple concurrent IT projects.
• Manage interdependencies between enterprise systems, manufacturing systems, laboratory systems, infrastructure, cybersecurity, and data platforms.
• Ensure completed projects transition effectively to system owners, support teams, and operational functions.
• Manage relationships with implementation partners, vendors, system integrators, consultants and internal SMEs.

Skills

Project management

Stakeholder management

Regulated life sciences

GxP knowledge (21 CFR Part 11)

IT/OT coordination

Vendor management

Communication skills

Planning and organization

Education

Bachelor’s degree in IT or related

Tools

ERP systems (Dynamics 365, Oracle, SAP, NetSuite)

LIMS and data systems

CSV/CSA knowledge

Job description

August Bioservices is seeking an IT Project Manager in Nashville to lead enterprise IT initiatives across ERP, LIMS, Data Historian, MES/eBR, and other systems. You will coordinate IT, Engineering, Manufacturing, Quality, Validation, and external partners to ensure on-time, within-budget delivery that meets regulatory expectations.

The ideal candidate has 5+ years in IT/digital transformation projects, especially in pharmaceutical or CDMO environments, with strong stakeholder and vendor