Project Manager- Supply Chain- cGMP

Project Overview:

This project involves managing and executing approximately 50 sub-tasks or sub-projects, with a critical timeline of 9-12 months, starting as soon as possible. The work must adhere to current Good Manufacturing Practices (cGMP) standards. The project manager will oversee all aspects of the initiative, ensuring timely completion and compliance while coordinating on-site and eventually hybrid work at the designated project location.

Responsibilities (Scope of Work):

Overseeing Execution: Manage the execution of over 50 sub-tasks and sub-projects, ensuring alignment with project goals.

cGMP Compliance: Ensure all activities adhere to cGMP standards throughout the project lifecycle, maintaining regulatory integrity.

Workstream Management: Simultaneously manage multiple workstreams and sub-project timelines to meet the 9-12 month deadline.

On-Site Coordination: Lead daily on-site work at the designated project location until the project reaches a stable condition.

Deliverables:

Detailed Project Plan: A comprehensive plan outlining all sub-tasks and sub-projects, including timelines, resources, and dependencies.

Progress Reports: Regular updates and reports to site and senior leadership, tracking milestones and addressing any issues.

Compliance Documentation: Records and documentation demonstrating adherence to cGMP standards, suitable for audits or reviews.

Final Project Report: A thorough report summarizing outcomes, challenges, and successes upon project completion.

Required Skills & Qualifications:

• Certification: PMP (Project Management Professional) or equivalent certification.
• cGMP Expertise: Proven experience with cGMP standards in a regulated industry (e.g., pharmaceuticals, biotech).
• Project Management: Strong ability to manage complex, multi-task projects with tools like Microsoft Project, Primavera, or similar.
• Leadership & Coordination: Experience leading teams, managing daily on-site operations, and transitioning to hybrid workflows.
• Communication: Excellent reporting and stakeholder management skills for updates to site and senior leadership.
• Adaptability: Comfortable working full-time on-site initially, then adjusting to a hybrid schedule.

Additional Notes:

• The project manager will act as the central point of contact, ensuring seamless coordination between sub-teams and compliance with both project and Client standards.
• Depending on the sub-tasks, supporting roles like Quality Assurance Specialists or cGMP SMEs might be needed, but the project manager will oversee their integration.

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