OPERATIONS / QUALITY ASSURANCE / SAFETY MANAGEMENT

Over 18 years of top performance in optimizing operations for up to 60K+ SF R&D facilities. A peak performer in establishing operational excellence in all facets of pre-clinical studies, encompassing best practices for quality, safety, compliance, and cost control. Adept at managing quality assurance for studies supporting pharmaceutical/biotech regulatory submissions by conducting independent audits, issuing audit reports, and recommending corrective actions. Empowering leader skilled in fostering cross-functional collaborations, including staff in decision-making process, and mentoring individual team members. KEY QUALIFICATIONS - Track record of successful FDA, USDA, AAALAC, IACUC, GLP, and COHSPULA inspections and audits as hands-on participant with “inspection ready” management philosophy. - Technically astute with expertise in administering and validating computer systems and monitoring regulatory environments, including critical laboratory equipment, security controls, and access systems. - Experienced in scientific operations, such as, animal handling and restraint, dosing and technical procedures, and aseptic techniques. Areas of Expertise * Multi-site Operations Management * Bioresearch Monitoring Management * Preclinical Compliance * Organizational Effectiveness * Corrective Action/Preventive Action (CAPA) * Quality / Access Control * Audits, Investigations & Reporting * Process & Procedure Development * Validation Testing * Project Planning & Management * Cross-functional Team Leadership * Micro-biologic Testing

Agricultural Technician

Hillsborough, NJ