Responsibilities: GLP Compliance Ensure internal, central, and local clinical laboratory activities are conducted in compliance with applicable Good Laboratory Practice (GLP) regulations, GCP requirements where applicable, company procedures, and industry standards. Monitor regulatory updates and emerging industry trends to ensure continued compliance and implementation of best practices. Support quality oversight of laboratory activities throughout the clinical study lifecycle. Quality Control & Quality Systems Develop, implement, maintain, and continuously improve laboratory quality control processes and procedures. Perform routine quality reviews and assessments to identify compliance gaps and opportunities for process improvement. Support the implementation of corrective and preventive actions (CAPAs) to address identified issues. Audits & Inspection Readiness Assist in planning, coordinating, and conducting internal laboratory audits to evaluate compliance with GLP requirements. Support regulatory inspections and external audits by preparing documentation, coordinating responses, and tracking commitments through completion. Participate in inspection readiness activities and support continuous audit preparedness. Documentation Management Review, maintain, and oversee controlled laboratory documentation, including Standard Operating Procedures (SOPs), protocols, reports, specifications, and quality records. Ensure laboratory documentation is accurate, complete, current, and compliant with GLP requirements and internal Quality Management System (QMS) procedures. Ensure laboratory-related Trial Master File (TMF) documentation is complete, accurate, and filed in a timely manner. Training & Compliance Support the development and delivery of GLP training for laboratory personnel. Provide guidance on quality processes, documentation standards, and regulatory expectations. Promote a culture of quality, compliance, and continuous learning across laboratory operations. Risk Management Assist in identifying, assessing, and documenting quality and compliance risks related to laboratory activities. Support the development and implementation of risk mitigation strategies. Monitor quality trends and recommend improvements to reduce compliance risk. Continuous Improvement Participate in continuous improvement initiatives that enhance laboratory quality systems, operational efficiency, and regulatory compliance. Collaborate with cross-functional stakeholders to implement process improvements and share best practices. Support quality metrics, trend analysis, and effectiveness monitoring. Cross-Functional Collaboration & Communication Partner with Clinical Operations, Translational Medicine, Regulatory Affairs, and laboratory vendors to support quality initiatives. Communicate quality-related issues, compliance status, risks, and improvement opportunities to management and key stakeholders. Foster collaborative relationships that support high-quality laboratory operations and inspection readiness. Qualifications:
| Location | Philadelphia, PA |