QC Start-up Lead — GMP Laboratory Operations

Kyowa Kirin North America; Sanford (NC); On-site; USD 137,300 - 185,000; Full time

Benefits offered by this job

401(k) with Company Match

Annual Bonus Program

Generous PTO and Holiday Schedule

Sick Days

Volunteer Days

Healthcare Benefits

HSA & FSA Programs

Well-Being and Work/Life Programs

Life & Disability Insurance

Tuition Assistance

Employee Referral Awards

Job summary

Kyowa Kirin North America in Sanford, NC, is seeking a Senior Manager, Quality Control to design, develop, and execute the operational readiness program for opening our QC laboratories at the new monoclonal antibody drug substance facility.

You will lead GMP readiness, technology transfer, and facility licensure activities, ensure compliance with 21 CFR Part 11 and ALCOA++, hire and develop QC staff, and drive performance metrics in a fast-scaling biotech environment.

Qualifications

• Bachelor's degree in life sciences or related field is required; a master's is preferred.
• Five+ years of GMP biopharmaceutical management experience is expected.
• Experience supporting startup/startup readiness and facility commissioning is a plus.

Responsibilities

• Provide technical leadership for QC startup activities, including design reviews and method transfer.
• Lead QC laboratory operations to achieve validation/qualification milestones for project readiness.
• Ensure 21 CFR Part 11 and Data Integrity compliance across laboratory records.
• Hire, onboard, and coach QC staff; develop training programs and staffing plans.
• Investigate deviations and CAPAs; establish KPIs for QC labs.
• Coordinate regulatory interactions and support inspections for the Sanford facility.

Skills

Leadership

Regulatory compliance

Quality control knowledge

Education

Bachelor's degree in life sciences or related field

Master's degree preferred

Tools

Empower

LIMS

ELN

LES

Microsoft Office Suite

Job description

Kyowa Kirin North America in Sanford, NC, is seeking a Senior Manager, Quality Control to design, develop, and execute the operational readiness program for opening our QC laboratories at the new monoclonal antibody drug substance facility.

You will lead GMP readiness, technology transfer, and facility licensure activities, ensure compliance with 21 CFR Part 11 and ALCOA++, hire and develop QC staff, and drive performance metrics in a fast-scaling biotech environment.