Gardner Resources Consulting, LLC

Compensation

Full Description

GLP Operational Quality Manager Key Responsibilities: · Support the GLP Operational Quality team and business partners in driving quality outcomes and operational excellence. · Maximize the value, impact, and delivery of quality oversight activities to ensure compliance and excellence in quality. · Collaborate with the Quality Analytics team to develop meaningful quality indicators for ongoing evaluation of process and quality system health, as well as risk identification. · Work closely with other R&D Quality members to support scalable quality approaches and ensure consistency in execution across products and programs. · Participate in regulatory document reviews, identifying potential risks or gaps in Investigator Brochures, INDs, BLAs, and NDA's. · Provide input in the development of audit scope and focus for vendor audits. · Contribute to pro-active inspection readiness activities by conducting quality assessments of GLP studies either on-site or remotely. · Collaborate with preclinical stakeholders and quality partners to develop appropriate metrics related to GLP activities. · Participate in creating and presenting content for annual GLP refresher training. Perform other duties as assigned. Requirements: · Bachelor's degree or equivalent in a related scientific field. · Strong experience in GLP (Good Laboratory Practices) and reviewing data and documents supporting GLP studies and submissions. · Experience in Pharmaceuticals or Contract Research Organization (CRO) · RQAP-GLP certification is preferred, but not mandatory. · Ability to work independently and meet timelines in a fast-paced environment. Excellent communication and collaboration skills. Travel Requirements: This role may require up to 20% travel.