Responsibilities
- Lead and oversee multiple GMP testing initiatives from start to completion.
- Develop and maintain detailed tracking systems such as schedules, action item logs, and dashboards to ensure accountability and on-time delivery.
- Monitor project progress, detect potential risks, and execute risk mitigation plans.
- Ensure all project outputs meet both client expectations and regulatory standards.
- Generate and deliver regular project updates and reports to internal and external stakeholders.
- Track, analyze, and report on turnaround times and schedule deviations.
- Act as the main client contact, ensuring clear communication and correct interpretation of technical information across teams.
- Organize and lead scheduled and impromptu project meetings, including kickoffs, status calls, technical visits, and closure sessions.
- Present project status and performance metrics during client business review meetings.
- Partner with the Business Development team to strengthen client relationships, drive revenue growth through cross-selling, and ensure outstanding service delivery.
- Monitor financial indicators such as full-time equivalent utilization, planned versus actual hours, budget variances, and cash flow.
- Ensure all testing processes adhere to GMP, GLP, and applicable regulatory requirements.
- Maintain precise and compliant documentation in line with Quality Management Systems.
- Assist in preparing for and supporting regulatory audits and client inspections.
- Drive timely resolution of investigations and related follow-ups.
- Work closely with cross-functional departments including Operations, Quality Assurance, Sample Registration, Pricing, and Business Development.
- Coordinate with affiliated laboratory sites and external subcontractors as needed.
