cGMP Implementation Project Management Program

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Company: Comptech Associates, Inc.

Location: Morris Plains, NJ 07950

Description:

Job Title: - cGMP Implementation Project Management Program
Duration: 6 Months
Location: Morris Plains, NJ (Initially 5x a week onsite, once project is stable 3x a week hybrid schedule)
No. of Positions: 1

JOB DESCRIPTION
  • This project involves the management and execution of approx. 50 sub-tasks or sub-projects, requiring adherence to current Good Manufacturing Practices (cGMP) for implementation.
  • The timeline for completion is critical, with a target duration of 9-12 months, starting as soon as possible.
  • The project manager will be responsible for ensuring that all tasks are completed on time and within the specified guidelines.
Client is looking for a cGMP (Current Good Manufacturing Practice) Project Manager
Scope of Work: The certified project manager will be responsible for:
1. Overseeing the execution of over 50 sub-tasks and sub-projects.
2. Ensuring adherence to cGMP standards throughout the project lifecycle.
3. Managing multiple workstreams and sub-project timelines simultaneously.
4. Coordinating daily on-site work until the project reaches a stable condition.
5. Transitioning to Client hybrid policy (minimum 3 days/week on-site) once the project is stable.

Deliverables:
1. Detailed project plan outlining all sub-tasks and sub-projects.
2. Regular progress reports and updates to site and senior leadership
3. Compliance documentation for cGMP standards.
4. Final project report upon completion.

Requirements:
  • 3-5 years PM experience
  • Experience with operations/process improvement
  • GMP or quality background
  • Ability to juggle multiple workstreams and sub-project timelines.
  • On-site presence required daily until the project is stable, followed by adherence to Client hybrid policy.
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