Chimerix

The Commercial Quality Assurance, Senior Manager reporting to the Director, Quality Assurance GMP will lead the disposition of commercial material from the manufacturing facility and 3PL, conducting and generating audit reports for vendors intended for commercial use. Additionally, this role will track and monitor trending QA metrics for commercial operations, generating Annual Product Reports, and providing oversight for Material Review Board meetings. The successful candidate will also be responsible for uploading commercial documents into Montrium, as well as reviewing and approving Master Batch Records for manufacturing and packaging.

• Review executed batch records for manufacturing, packaging, and labeling, handle commercial material disposition and release from CMO and 3PL
• Create SOPs as necessary for commercial GMP procedures
• Review and approve vendor change controls, deviations, and investigations
• Ability to lead the review and approving OOS results, specifications, product complaints and investigations.
• Examine and approve vendor CAPAs and generate Annual Product Review reports, along with Chimerix CAPAs, deviations, and change controls.
• Create Quality Agreements with commercial vendors
• Assist with CTM activities as time permits

• Minimum 8 years of successful QA leadership in biotech/pharma organization
• Bachelor’s degree in a related technical field
• Knowledge of various SDLC and their processes
• Commercial launch experience
• Experience with GxP quality systems and requirements
• GMP documentation, records management practices, and inspection readiness
• Detail oriented with strong interpersonal, oral and written communication skills in a teamwork environment.
• Ability to organize and track multiple tasks in a dynamic teamwork environment.