QC Manager, Lab Support

About this role

We are seeking an experienced and motivated QC Manager, Lab Support to lead the lab support function within our biologics drug substance manufacturing facility. This role is critical to ensuring seamless QC laboratory operations, overseeing sample management, stability programs, and core lab support activities that enable compliant, inspection-ready performance.

As a key leader, you will drive operational excellence, support both clinical and commercial manufacturing, and ensure alignment across QC and manufacturing teams. This is an onsite role (Monday–Friday) with occasional off-shift and weekend support as needed.

What you’ll do

• Lead and develop the QC Lab Support team, overseeing hiring, training, performance, and daily operations
• Manage core lab support activities including sample management, stability pulls, equipment cleaning, autoclave/glass wash operations, and lab supply coordination
• Ensure equipment readiness, calibration, lifecycle management, and support OOT investigations
• Maintain GMP compliance, audit readiness, and data integrity across all lab support processes
• Drive deviation investigations, CAPAs, and continuous improvement initiatives
• Optimize and standardize lab support processes, including procedures and training programs
• Partner cross-functionally with QC and manufacturing to align support with testing and production needs
• Manage resources, staffing, and budget to ensure efficient, cost-effective operations

Who you are

You are a strategic, results-driven leader with strong expertise in GMP quality control operations. You bring a passion for developing teams, driving continuous improvement, and ensuring high-quality, inspection-ready laboratory environments.

Required skills

• Bachelor’s degree in Biological Sciences or related field
• Minimum 5 years of QC experience managing samples and stability pulls in a GMP-regulated biologics or pharmaceutical environment
• At minimum 2 years of supervisory or team leadership experience
• Experience with autoclave and glasswasher operations
• Experience supporting equipment/instrument lifecycle management and OOT investigations
• Experience supporting regulatory inspections and maintaining audit readiness
• Proficiency with systems such as LIMS, Smart QC, Excel, and PowerPoint

Preferred skills

• Prior experience leading sample management or lab support teams
• Project management experience