Lead technical-writing activities for the Compliance team, including procedures, process flows, regulatory and audit responses, and reports associated with trending, deviations, investigations, and validation.Lead quality-process improvements that strengthen GxP testing operations, systems, procedures, and documentation practices.Conduct detailed laboratory data and in-lab process reviews to support the integrity, accuracy, completeness, and quality of GxP data.Collaborate with Quality Assurance to maintain alignment with company policies and applicable federal regulations and support ongoing inspection readiness.Participate in regulatory inspections and internal Quality Assurance audits, including related preparation and follow-up activities.Monitor laboratory operations and quality metrics, identify trends, and drive related processes and procedural improvements.Evaluate system data integrity and end-to-end data flows, identify opportunities for enhancement and/or modernization, and participate in validation of computer and laboratory systems.Develop and/or update procedures supporting documentation reviews and process reviews.Lead training and coach department staff on adherence to SOPs, documentation requirements, procedures, assays, and laboratory systems.Participate in and/or lead internal initiatives that strengthen quality operations and support the setup of the new facility and laboratories.
