Manager, Quality Control - Remote

Overview

The Quality Control Manager will support Quality Control aspects for GMP Operations in all phases of product development, ensuring compliance and quality in the production of RNA therapeutics.

In Short

• Provide oversight of QC activities at external CMOs/CTOs.
• Be the point of contact for selective CMOs/CTOs from initiation of vendor contact through release and stability testing.
• Support analytical technology transfers to CTOs and CMOs.
• Enable testing activities within Avidity’s CMO and CTO network.
• Support the QC team with development of systems and tools.
• Proactively identify and troubleshoot issues.
• Drive deviation/OOS investigations and implement CAPAs.
• Communicate data verbally and through written documents.
• Assist in the preparation of CMC regulatory submissions.
• This position may require travel (5-10%).

Requirements

• BS or MS in a related field.
• 5+ years of related experience in QC management.
• Working knowledge of antibody and oligonucleotide analytical methods.
• Demonstrated knowledge of cGMP/ICH/FDA regulations.
• Excellent interpersonal and communication skills.
• Experience managing CMO relationships.

Benefits

• Competitive compensation and benefits.
• Annual and spot bonuses, stock options, and RSUs.
• 401(k) with employer match.
• Comprehensive wellness program.
• Commitment to learning and development.