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.
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