Job Description

We are seeking a highly experienced IT Project Manager – Scrum Master to lead the implementation of an FDA-regulated Quality Document Management System (QDMS). This role requires a seasoned Agile practitioner with a deep understanding of regulatory environments and experience in systems integration, particularly in pharmaceutical or highly regulated industries. The successful candidate will lead the Agile team using Scrum methodologies while ensuring compliance with regulatory standards like 21 CFR Part 11. The ideal candidate will have hands-on experience with tools such as Microsoft Project, Azure DevOps, and Microsoft PowerPoint, and will serve as the key liaison between cross-functional teams including IT, Quality Assurance, and Regulatory Affairs. Key Responsibilities Facilitate all aspects of the Agile Scrum process, including sprint planning, daily standups, retrospectives, and reviews. Collaborate closely with the Product Owner to prioritize and manage the product backlog. Develop and maintain detailed project plans and cutover strategies using Microsoft Project. Ensure all deliverables meet FDA compliance standards, particularly in relation to 21 CFR Part 11. Coordinate with subject matter experts and stakeholders to ensure regulatory alignment. Support system validation, testing, and documentation in line with SDLC and audit requirements. Lead user training and change management initiatives to drive system adoption. Monitor project progress, address impediments, and apply continuous improvement strategies. Manage stakeholder communication and expectations throughout the project lifecycle. Facilitate workshops and knowledge-sharing sessions across departments. Required Qualifications Minimum 7 years of experience in project management, including Agile/Scrum methodologies. Demonstrated experience in systems integration projects. Proficiency in Microsoft Project, PowerPoint, and Azure DevOps. Proven experience with Agile project delivery in FDA-regulated environments. Excellent interpersonal, leadership, and facilitation skills. Strong understanding of FDA compliance requirements and validation documentation. Preferred Qualifications Experience with SAP SuccessFactors, Singlepoint Document Management, or Trackwise Digital. Knowledge of regulated SDLC processes and validation in life sciences or pharma. Familiarity with enterprise document management systems and quality assurance frameworks. Certifications (if any) SAFe Certification is a strong plus. Certified Scrum Master (CSM) or equivalent Agile certification preferred. #J-18808-Ljbffr Compunnel, Inc.

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