Overview
Skills
Job Details
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 re 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.