KBI: US - Project Manager

KBI Biopharma•Durham, NC

1d•Hybrid

About The Position

Senior SAP IT Pro gram Manager Position Summary The Senior SAP IT Pro gram Manager leads complex, global SAP S/4HANA implementation and migration initiatives within a highly regulated pharmaceutical environment. This role ensures successful delivery of SAP enhancements and bug fixes in compliance with FDA, GxP , SOX, and data integrity standards, using Agile and hybrid delivery methods. The ideal candidate brings a deep understanding of SAP transformation programs, validated systems, and the unique needs of the pharmaceutical industry, supported by proven expertise in Jira-based Agile execution. Key Responsibilities Lead end-to-end planning and execution of SAP S/4HANA changes , including design, configuration, testing, validation, and cutover. Define project scope, objectives , and success criteria in collaboration with business and IT stakeholders. Drive Agile and hybrid delivery frameworks, including sprint planning, backlog grooming, retrospectives, and velocity tracking using Jira and Confluence. Coordinate cross-functional teams (Finance, Supply Chain, Manufacturing, Quality, and IT) to ensure alignment of business processes and system capabilities. Oversee Computer System Validation (CSV) and documentation activities in accordance with 21 CFR Part 11 and GAMP 5 principles. Manage project budgets, forecasts, timelines, and vendor deliverables to ensure on-time, in-scope, and compliant delivery. Provide oversight of technology vendor resourcing. Facilitate discussions regarding data integration and governance. Early risk identification and management; m aintain robust risk, issue, and change management processes in compliance with PMO governance and CSV requirements. Facilitate executive-level reporting, steering committee meetings, and stakeholder communications. Lead definition, tracking, and management of SAP success measures. Drive continuous improvement and adoption of Agile methodolog y across SAP programs. Serve as the SAP IT organizational change management lead . Serve as a key liaison between IT, QA, Validation, and Business Process Owners to ensure regulatory readiness and audit compliance. Champion SAP technology best practices.

Requirements

Bachelor’s degree in computer science, Engineering, Information Systems, or related field ( master’s preferred).
8–12 years of progressive IT project management experience, including 5+ years leading SAP programs.
Minimum 3 years managing SAP S/4HANA implementations or global transformations.
Experience in the pharmaceutical or life sciences industry with demonstrated understanding of FDA, GxP , and CSV requirements .
Proven experience using Jira and Confluence for Agile delivery and tracking .
Familiarity with SAP Activate methodology and best practices for validated environments.
Strong understanding of key SAP modules such as MM, PP, QM, FI/CO, and Supply Chain.
Deep knowledge of SAP S/4HANA program management within regulated ( GxP ) environments.
Strong leadership and stakeholder management across global, cross-functional teams.
Excellent communication, facilitation, and conflict-resolution skills.
Expertise in Agile methodologies and Jira/Confluence-based reporting.
Financial acumen in managing multimillion-dollar transformation programs.
Ability to lead change in a dynamic, matrixed organization while ensuring compliance and quality.
Adept at working through ambiguity.
Must work effectively in a fast-paced, regulated, and multinational environment.

Nice To Haves

Desired experience with C ontract Development and Manufacturing Organi zation (C DMO ) specific operational models and CDMO SAP implementations.
PMP or PRINCE2
Certified Scrum Master (CSM) or PMI-ACP
SAP Activate Project Manager or SAP Solution Manager certification

Responsibilities

Lead end-to-end planning and execution of SAP S/4HANA changes , including design, configuration, testing, validation, and cutover.
Define project scope, objectives , and success criteria in collaboration with business and IT stakeholders.
Drive Agile and hybrid delivery frameworks, including sprint planning, backlog grooming, retrospectives, and velocity tracking using Jira and Confluence.
Coordinate cross-functional teams (Finance, Supply Chain, Manufacturing, Quality, and IT) to ensure alignment of business processes and system capabilities.
Oversee Computer System Validation (CSV) and documentation activities in accordance with 21 CFR Part 11 and GAMP 5 principles.
Manage project budgets, forecasts, timelines, and vendor deliverables to ensure on-time, in-scope, and compliant delivery.
Provide oversight of technology vendor resourcing.
Facilitate discussions regarding data integration and governance.
Early risk identification and management; m aintain robust risk, issue, and change management processes in compliance with PMO governance and CSV requirements.
Facilitate executive-level reporting, steering committee meetings, and stakeholder communications.
Lead definition, tracking, and management of SAP success measures.
Drive continuous improvement and adoption of Agile methodolog y across SAP programs.
Serve as the SAP IT organizational change management lead .
Serve as a key liaison between IT, QA, Validation, and Business Process Owners to ensure regulatory readiness and audit compliance.
Champion SAP technology best practices.