Position SummarycGMP Consulting is seeking a motivated and detail-oriented individual to project manage engineering activities to ensure client projects are executed efficiently, on time, and within budget. This senior-level role offers independent leadership and responsibilities in a dynamic, GMP-compliant manufacturing environment.
The ideal candidate excels in leading cross-functional collaboration, organization and completion of multiple high-level projects. This candidate should have a strong understanding of current Good Manufacturing Practices (cGMP) and FDA regulations and guidelines.
This position is open year round.
Responsibilities The essential functions include, but are not limited to the following:
- Develop and oversee project plans, timelines, deliverables and resource allocation.
- Monitor progress, manage risk and coordinate resources across multiple concurrent projects.
- Serve as 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 (e.g., protocols, reports, assessments, remediation plans) for completeness, clarity, and alignment with GMP 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 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.
Requirements - Minimum Bachelors' degree in Engineering, Science, or a related field of study.
- 4+ years' experience in a GMP manufacturing environment, including leading project deliverables. Must be familiar with regulatory (FDA) requirements.
- PMP, CAPM, or equivalent project management certification.
- Excellent organizational, communication, and stakeholder-management skills.
- Ability to manage multiple complex projects simultaneously.
- Proficiency with project management tools and methodologies.
Compensation and Benefits - Expected pay range per year: $85,000-$100,000 USD
- Expected benefits include: Medical, Dental, Vision, PTO, 401K
Disclaimer The duties and responsibilities described are not a comprehensive list and additional tasks may be assigned to the employee from time to time; or the scope of the job may change as necessitated by business demands. All duties and responsibilities are subject to possible modification to reasonably accommodate individuals with disabilities. The requirements listed are the minimum levels of knowledge, skills, or abilities necessary to perform this job successfully.
