Head of Quality Control

About the role

We are hiring a Head of Quality Control to establish and lead a rigorous, fast and transparent Quality Control function for our clinical-stage programs. You will be accountable for the QC laboratory’s operations and readiness: how samples are managed, tests are performed and reviewed, methods enter routine use, investigations are conducted, and the team is trained.

What you'll do

• Set QC strategy, laboratory priorities, staffing plans and performance measures for the laboratory
• Establish traceable sample workflows, from request and receipt through storage, testing, review, and reporting
• Work with Analytical Development to bring methods into QC. Ensure methods are fit for their intended use and appropriately transferred, verified, qualified
• Establish and maintain controls for specifications, stability testing, reference standards, reagents, instruments, calibration, maintenance, and laboratory documentation
• Ensure results are reviewed promptly and consistently, with clear escalation of unexpected or potentially significant findings

What you need

• 10–18 yrs of experience
• Quality control
• GMP
• Microbiology
• HPLC
• Chemistry
• Root cause analysis
• PhD

Good to have

• Regulatory affairs