Senior Quality Engineer - Qualified Person

Labcorp is a global leader in laboratory services, providing the insights and answers that help healthcare providers, patients, researchers, pharmaceutical companies and health systems make confident decisions and improve outcomes. Through our unparalleled science, data, technology and laboratory network, we advance diagnostics, accelerate innovation and help address some of the world’s most important health challenges. As we shape the future of healthcare, we are leveraging advanced technologies, intelligent digital solutions and data-driven innovation across our operations to enhance how work gets done and deliver greater value to customers and patients. With our global scale and deep expertise, you’ll have the opportunity to do meaningful work, grow your career and make a real impact on people’s health around the world. Together, we’re improving health and improving lives. Labcorp is seeking an onsite Senior Quality Engineer - Qualified Person to join our brand new CMC facility in Mechelen, Belgium.

Supports the implementation of a quality management system that complies with domestic and international regulations. Ensures local compliance with the QMS requirements. Plays a leading role in the implementation of a quality management system that complies with domestic and international regulations. Ensures local compliance with the QMS requirements. Oversees, and approves Quality Related Issue Resolutions, Corrective / Preventive Actions (CAPA), Change Controls, Vendor Management, Complaint Handling, Continual Improvement and NCM/MRB systems, as appropriate. Engineers solutions to address product and process quality issues. Supervisory responsibility for a segment of the QA team providing workload assignment, recruitment, performance evaluation, professional and personal training and development, implementation and follow-up of site departmental objectives, etc. May deputize for the Site QA Lead. Monitors, compiles and reports on appropriate quality metrics and data trends related to the local performance of the quality management system for input into the Management Review Process; assess and report post-market surveillance data in accordance with regulatory requirements. Promote awareness of the applicable regulations and associated quality management system and lead the development / delivery of regulatory based training including quality management principles and risk management practices. Supports the annual audit program by scheduling, planning, leading, reporting and following up of internal audits, leading/supporting external vendor assessments and hosting regulatory and client inspections Study Specific Oversight - Pharmaceutical GMP Studies: Provides regulatory approval and accountability for release (or rejection) of study related documentation (i.e. batch records, methods, protocols, reports, certificates of analysis, etc.) and/or pharmaceutical material/product for use in clinical trials. Represents QA on key projects to ensures facilities, utilities, equipment and computer systems are appropriately validated/qualified; approval of key validation deliverables Reviews and approves controlled documents (SOPs, Policies, etc.) to ensure compliance with applicable regulations, document management procedures and other relevant quality standards Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed. Where needed provides QP confirmation statements for associated certificates of analysis Other duties as assigned by management.

Certified Qualified Person by FAMHP Master degree in Pharmacy 5 or more years experience in quality-related work Preferred Qualifications Bachelor degree in life science 5 or more years of experience in working with quality management systems and applicable regulations 1 or more years experience in pharmaceutical or biotech industry in a global organization 1 or