QC Lab Start-Up Director

Socket.dev; Sanford (NC); On-site; USD 157,000 - 206,000; Full time

Benefits offered by this job

401K matching

Annual bonus program

Generous PTO and holidays

Healthcare benefits

Tuition assistance

Employee referral awards

Job summary

Kyowa Kirin North America is seeking an experienced Associate Director of Quality Control to lead startup QC laboratories in Sanford, NC. You will guide analytical method transfer, instrumentation qualification, and regulatory readiness for Phase III and commercial products.

The role emphasizes team leadership, cross-functional collaboration, and strong adherence to GxP and 21 CFR Part 11 standards in a fast-evolving biotech environment.

Qualifications

• Requires 10+ years of management experience leading GMP Bio-Pharmaceutical QC laboratories and support areas.
• Experience managing QA teams within biopharmaceutical manufacturing operations.
• Starting up and operating a biopharma manufacturing facility a plus.

Responsibilities

• Lead QC Lab operations to meet validation and qualification milestones for startup and commissioning.
• Ensure laboratory systems comply with 21 CFR Part 11 and data integrity (ALCOA++) requirements.
• Hire, onboard, train, and mentor QC staff per staffing plans.

Skills

GMP Knowledge

Quality Control

Leadership

Regulatory Compliance

Education

Bachelor’s degree in life sciences

Master’s degree in life science

Tools

Empower

LIMS/ELN

MS Office

Job description

Kyowa Kirin North America is seeking an experienced Associate Director of Quality Control to lead startup QC laboratories in Sanford, NC. You will guide analytical method transfer, instrumentation qualification, and regulatory readiness for Phase III and commercial products.

The role emphasizes team leadership, cross-functional collaboration, and strong adherence to GxP and 21 CFR Part 11 standards in a fast-evolving biotech environment.