cGMP Consulting Inc. · 14 hours ago
IT Project Manager
cGMP Consulting Inc. specializes in providing validation, qualification, and compliance services to the life sciences industry. They are seeking an experienced IT Project Manager to lead technology initiatives that support compliant and efficient production operations in pharmaceutical manufacturing.
Pharmaceutical
Responsibilities
Lead end-to-end project lifecycle activities including scope definition, requirements gathering, scheduling, resourcing, budgeting, risk management, and execution
Manage multiple concurrent IT and manufacturing systems projects (e.g., MES, ERP, LIMS, automation integrations, data platforms)
Develop clear project plans, charters, and communication strategies for stakeholders across IT, Quality, Manufacturing, Supply Chain, and Engineering
Partner with manufacturing, QA, validation, and engineering teams to align project delivery with GMP and operational needs
Facilitate workshops, requirements sessions, and steering committee updates
Coordinate with external vendors, software providers, and system integrators
Ensure all IT project deliverables meet GxP, 21 CFR Part 11, Annex 11, and internal quality system requirements
Work with QA and CSV/validation teams to develop validation plans, protocols, and documentation aligned with software development life cycle and industry best practices
Maintain project documentation consistent with audit and regulatory expectations
Support implementation and enhancement of manufacturing technology such as, MES (e.g., Werum PAS-X, Rockwell PharmaSuite), ERP (e.g., SAP S/4HANA), LIMS / ELN, SCADA, equipment integration, data historians (e.g., PI), Serialization, traceability, and digital quality systems
Translate business and manufacturing requirements into system specifications and functional designs
Troubleshoot and escalate complex technical issues with appropriate teams
Drive process standardization, integration, and digital transformation initiatives within manufacturing IT
Identify opportunities to optimize system performance, data flows, and compliance posture
Contribute to long-term technology roadmaps and system upgrades
Qualification
Required
Bachelor's degree in Information Technology, Computer Science, Engineering, or related field
5+ years of IT project management experience, with at least 3 years in pharmaceutical, biotech, or regulated manufacturing
Strong understanding of GMP, CSV, GxP regulations, and computerized system validation
Demonstrated success leading cross-functional IT/mfg system projects
Excellent communication, organizational, and stakeholder management skills
Experience with common project methodologies (Waterfall, Agile, or hybrid)
Benefits
Medical
Dental
Vision
PTO
401K
Company
cGMP Consulting Inc.
Founded in 2001, cGMP Consulting Inc.
H1B Sponsorship
cGMP Consulting Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (2)
2023 (2)
2022 (3)
Funding
Current Stage
Growth StageCompany data provided by crunchbase