Role Overview
The GMP Testing Project Manager is responsible for planning, coordinating, and overseeing Good Manufacturing Practice (GMP)-compliant testing projects within a regulated laboratory environment. This role ensures timely delivery of testing services, adherence to regulatory standards (FDA, EMA, ICH), and effective communication with internal teams and external clients.
Key Responsibilities
- Project Management
- Lead and manage multiple GMP testing projects from initiation to closure.
- Establish and maintain comprehensive tracking tools for projects, including schedules, action trackers and dashboards to enforce accountability and timely delivery.
- Monitor progress, identify risks, and implement mitigation strategies.
- Ensure all deliverables meet client expectations and regulatory requirements.
- Prepare and present project updates and reports to internal and external stakeholders.
- Track, manage and report turnaround time metrics and schedule variance.
- Client Communication
- Serve as the primary point of contact for clients, ensuring clear communication and accurate interpretation of technical data across functional teams.
- Organize and facilitate planned and ad hoc project meetings including: project kick off, recurring project status calls, client technical visits, and project closure meetings.
- Prepare and present project status and performance KPIs in client Business Review Meetings.
- Financial Management
- Work closely with the Business Development team to grow client relationship and revenue through cross selling and managing assigned projects to provide exemplary customer experience and value
- Track financial performance - including FTE utilization, planned vs actual hours, budget variance, and cash flow.
- Compliance & Quality
- Ensure testing activities comply with GMP, GLP, and relevant regulatory guidelines.
- Maintain accurate documentation in accordance with Quality Management Systems (QMS).
- Support audits and inspections by regulatory authorities and clients.
- Drive investigations to timely closure.
- Team Collaboration
- Collaborate with cross-functional teams (Operations, QA, Sample Registration, Pricing, Business Development).
- Collaborate with partner Eurofins sites and subcontractors as required.