Remote Sr. Manager, GMP Quality

Overview

The Fountain Group is currently seeking a Remote Sr. Manager, GMP Quality for a prominent client of ours. Details for the position are as follows:

• Pay: $80-102.63/hr.
• 6-month assignment with possibility for extension or conversion based on performance and budget.

• Serve as QA representative on cross-functional project teams.
• Lead QA communication with domestic and international CMOs and suppliers.
• Perform product release and final batch disposition for clinical and commercial products.
• Review and approve Master and Executed Batch Records, stability data, and release documentation.
• Support technical transfers, process validation, and commercial manufacturing readiness.
• Review and approve validation protocols and reports.
• Lead and manage quality events: deviations, investigations, CAPA, change controls, and complaints in eQMS.
• Ensure GMP compliance and drive continuous improvement of SOPs and quality systems.
• Author, review, and approve SOPs and quality documentation.
• Support Annual Product Reviews with data analysis and recommendations.
• Act as Person-in-the-Plant when required.

• Bachelor’s degree in a scientific discipline with 8+ years of pharmaceutical/biotech experience, primarily in Quality.
• Strong QA experience in GMP pharmaceutical/biotech manufacturing.
• Proven batch record review/approval and final product disposition experience.
• Advanced knowledge of GMPs and pharmaceutical manufacturing/release processes.
• Experience managing CMOs, contract labs, and external suppliers.
• Expertise in quality events: investigations, CAPA, change control, and complaints.
• Excellent technical writing and documentation skills.
• Experience improving quality systems, SOPs, and compliance workflows.

If you are interested in hearing more about the position, please respond to this posting with your resume attached.

Please forward this posting to any friends or colleagues as we do offer a Referral Bonus for any candidate hired.

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