Senior Commercial QC Lab Manager — cGMP & Release Expert

Medium; Bend (OR); On-site; USD 120,000 - 180,000; Full time

Job summary

Serán is seeking a Commercial Quality Control Laboratory Manager to lead the daily operations of the QC Laboratory in Bend, Oregon, supporting commercial manufacturing, product release, and stability testing under cGMP, ICH, and FDA guidelines.

You will mentor staff, manage testing schedules, ensure timely releases, and drive continuous improvement and data integrity (ALCOA++), while coordinating with Manufacturing, QA, and Supply Chain for on-time product disposition and audits.

Qualifications

• Bachelor’s degree in chemistry, physics, engineering, or related scientific discipline.
• 5+ years of GMP experience in quality control laboratory.
• 5–10 years of relevant laboratory experience with prior management.
• Experience supporting FDA, client, and regulatory inspections.

Responsibilities

• Lead daily operations of the Commercial Quality Control laboratory.
• Recruit, train, and develop QC personnel; set performance expectations.
• Oversee release, in-process, raw material, cleaning verification, stability testing.
• Manage investigations, OOS/OOT events, deviations, CAPAs, change controls.
• Ensure ALCOA++ data integrity and inspection readiness.
• Support internal and client audits and regulatory inspections.
• Coordinate testing priorities with manufacturing and supply chain.

Skills

Leadership

cGMP knowledge

FDA/ICH compliance

Analytical testing knowledge

LIMS/Empower/NuGenesis

Quality investigations OOS/OOT

Project management

Data integrity / ALCOA++

Education

Bachelor’s degree in a scientific discipline

Advanced degree preferred

Tools

LIMS

Empower

NuGenesis

Chromatography instrumentation

Job description

Serán is seeking a Commercial Quality Control Laboratory Manager to lead the daily operations of the QC Laboratory in Bend, Oregon, supporting commercial manufacturing, product release, and stability testing under cGMP, ICH, and FDA guidelines.

You will mentor staff, manage testing schedules, ensure timely releases, and drive continuous improvement and data integrity (ALCOA++), while coordinating with Manufacturing, QA, and Supply Chain for on-time product disposition and audits.