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cGMP Consulting

cGMP compliance consulting for pharma

Project Manager

Full-Time
$85k - $100k/yr
Mid
Bachelor's
Chicago Metropolitan Area, USA
In PersonWork is based around client sites in Illinois and Wisconsin.
Project & Program ManagementProject Management

About the job

Requirements
  • A minimum bachelor's degree in Engineering, Science, or a related field of study.
  • At least four years of experience in a Good Manufacturing Practice (GMP) manufacturing environment, including leading project deliverables.
  • Familiarity with Food and Drug Administration (FDA) requirements.
  • A Project Management Professional (PMP), Certified Associate in Project Management (CAPM), or equivalent project management certification.
  • Strong organizational, communication, and stakeholder-management skills.
  • Ability to manage multiple complex projects simultaneously.
  • Proficiency with project management tools and methodologies.
Responsibilities
  • Develop and oversee project plans, timelines, deliverables, and resource allocation.
  • Monitor project progress, manage risk, and coordinate resources across multiple concurrent projects.
  • Serve as the main point of contact for client projects, ensuring clear communication, expectation alignment, and proactive issue resolution.
  • Facilitate project kickoff meetings, status updates, and closeout sessions with client stakeholders.
  • Work cross-functionally with stakeholders, subject matter experts, contractors, and other site personnel.
  • Ensure project objectives align with client needs and regulatory requirements.
  • Review and approve project deliverables, including protocols, reports, assessments, and remediation plans, for completeness, clarity, and alignment with Good Manufacturing Practice expectations.
  • Maintain accurate project records, including meeting minutes, action logs, risk registers, and change controls.
  • Contribute to continuous improvement of internal project management processes, tools, and methodologies.
  • Manage project budgets, track hours, and ensure alignment with the contracted scope of work.
  • Identify scope changes and support development of change orders or revised proposals.
  • Deliver accurate forecasting and financial reporting to internal leadership.
  • Provide direction, coaching, and support to project team members to ensure effective execution.
  • Foster a collaborative, transparent working environment across internal and client teams.

About the company

cGMP Consulting helps pharmaceutical and biotech firms comply with current Good Manufacturing Practices (cGMP) and Title 21 CFR requirements. It provides engineering and quality assurance consulting, conducts gap analyses, and helps design and implement compliant processes, documentation, and validation across international manufacturing sites. The team combines engineering and QA expertise with hands-on implementation, not just advisory guidance. Its goal is to help clients adopt new technologies while meeting cGMP and regulatory expectations for efficient, compliant pharmaceutical manufacturing worldwide.

Company Size

51-200

Company Stage

N/A

Total Funding

N/A

Headquarters

Georgia

Founded

2001

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Simplify Jobs

Simplify's Take

What believers are saying

  • August 2026 posts on interim leadership, CSV, and facility design show active demand.
  • May 2026 Engineer I posting proves continued hiring across validation work.
  • Website updated September 5, 2026, signals an operating firm still marketing for new projects.

What critics are saying

  • No proprietary software or IP; staffing utilization drives revenue every quarter.
  • Built for FDA-regulated industries, so pharma capital spending slows projects by Q4 2026.
  • Career page hiring shows growth dependence; any client loss hits bench utilization fast.

What makes cGMP Consulting unique

  • 25-year cGMP validation, engineering, audits, and compliance focus wins regulated clients.
  • More than 75 consultants cover CQV, engineering support, operations, and regulatory compliance.
  • Lake Forest, Illinois base plus client-site delivery across Midwest manufacturing hubs.

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Benefits

  • Health Insurance
  • Dental Insurance
  • Vision Insurance
  • Paid Vacation