Senior GMP Project Manager (Life Sciences)

cGMP Consulting; Cincinnati (OH); In loco; USD 85.000 - 100.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical

Dental

Vision

PTO

401K

Descrizione del lavoro

cGMP Consulting is seeking a senior project manager to lead engineering activities in GMP-compliant manufacturing settings, ensuring client projects are executed efficiently, on time, and within budget.

The role requires strong cross-functional leadership, communication with stakeholders, and a solid understanding of FDA regulations. This year-round position offers independent responsibility and opportunities to drive continuous improvement across projects.

Competenze

• Bachelor's degree in Engineering, Science, or related field.
• PMP or CAPM certification preferred.
• Experience in GMP manufacturing and FDA regulations.
• Strong organizational and communication skills.
• Ability to manage multiple complex projects.

Mansioni

• 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.

Conoscenze

Project management

Cross-functional collaboration

Organizational skills

Communication skills

Stakeholder management

Formazione

Bachelor's degree in Engineering or Science

Strumenti

PMP

CAPM

Descrizione del lavoro

cGMP Consulting is seeking a senior project manager to lead engineering activities in GMP-compliant manufacturing settings, ensuring client projects are executed efficiently, on time, and within budget.

The role requires strong cross-functional leadership, communication with stakeholders, and a solid understanding of FDA regulations. This year-round position offers independent responsibility and opportunities to drive continuous improvement across projects.