Quality Control Director — cGMP Data-Driven Leader

Samsung BioLogics Co.; Rockville, Northern (MD, KY); Hybrid; USD 180,000 - 240,000; Full time

Job summary

Samsung BioLogics Co. in Rockville, MD seeks a Director of Quality Control to lead a cGMP QC lab. You will mentor leaders, guide analysts, and ensure data integrity in sampling, testing, and data review in line with ALCOA principles.

You will assure regulatory compliance (GMP, NIH, ICH, FDA) and drive timely investigations and investigations closure, while supporting IND/BLA/MAA filings and internal projects.

Qualifications

• Bachelor’s degree in a science discipline.
• 10+ years of industrial biopharmaceutical experience.
• 8+ years of supervisory/managerial experience.
• Experience with GMP, NIH, ICH, FDA regulatory requirements for analytical/ stability operations.
• Strong communication and cross-functional leadership.

Responsibilities

• Lead and empower QC laboratory leaders to ensure data integrity per ALCOA.
• Provide technical guidance to analysts and supervisors in QC Laboratory and Operations.
• Ensure compliance with GMP, NIH, ICH, FDA regulatory requirements for validation and operations.
• Support regulatory submissions (IND, BLA, MAA) as needed.
• Oversee sample management, environmental monitoring, and release testing for components, intermediates, APIs, and finished products.
• Represent QC on projects and committees within Samsung.

Skills

Leadership

Regulatory compliance

GMP knowledge

Analytical chemistry

Microbiology

Education

Bachelor's degree in a science discipline

Job description

Samsung BioLogics Co. in Rockville, MD seeks a Director of Quality Control to lead a cGMP QC lab. You will mentor leaders, guide analysts, and ensure data integrity in sampling, testing, and data review in line with ALCOA principles.

You will assure regulatory compliance (GMP, NIH, ICH, FDA) and drive timely investigations and investigations closure, while supporting IND/BLA/MAA filings and internal projects.