Clinical Quality Management Manager

Job Summary

A company is looking for a Principal Manager, Clinical Quality Management.

Key Responsibilities

• Manage document development, revision, and retirement in alignment with sponsor procedures and quality standards
• Lead collaborative reviews and drive resolution of edits/comments with relevant stakeholders
• Support internal and external audits by providing documentation and ensuring timely resolution of audit findings

Required Qualifications and Education

• Bachelor's degree in a life sciences discipline is highly preferred
• 8-10 years of experience in the biopharmaceutical industry or equivalent education and experience
• Experience in Sponsor/CRO GCP and project management is required
• Strong operational understanding of Clinical Trials and GCP
• Interest in Process/Controlled Document Management is essential