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.
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.
Qualifications
- Bachelor’s degree in chemistry, Biology, Pharmaceutical Sciences, or related field.
- Authorization to work in the United States indefinitely without restriction or sponsorship.
- Strong background in pharmaceutical sciences, analytical chemistry, or biologics.
- Experience in GMP lab operations, especially in CMC testing.
- Proven ability to manage complex projects and cross-functional teams.
- Familiarity with regulatory requirements and quality standards.
- Excellent communication and client management skills.
Skills
- Knowledge of GMP regulations (21 CFR Part 210/211, EU GMP).
- Excellent organizational and time-management skills.
- Proficiency in project management tools (MS Project, Smartsheet).
- Strong communication and stakeholder management abilities.
Benefits
- Comprehensive medical coverage.
- Life and disability insurance.
- 401(k) with company match.
- Paid holidays and vacation.
- Dental and vision options.
Position Details
Position is full-time, Monday-Friday, 8:00 a.m.-4:00 p.m., plus additional hours as needed. Candidates currently living within a commutable distance of Lancaster, PA are encouraged to apply.
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