Quality Control Director — Data-Driven Lab Leadership

Samsung Biologics RKV; Rockville (MD); On-site; USD 140,000 - 210,000; Full time

Job summary

Samsung Biologics is seeking a senior QC leader to guide a cGMP Quality Control laboratory supporting manufacturing and development activities. You will lead a team of lab leaders and analysts, providing technical guidance and ensuring ALCOA data integrity across sampling, testing, and data review.

Responsibilities include ensuring regulatory compliance (FDA/ICH/GMP), coordinating investigations, mentoring staff, and representing QC on cross-functional projects while supporting regulatory

Qualifications

• Bachelor’s degree in a science discipline.
• 10+ years in biopharmaceutical industry with 8+ years in supervision.
• Strong knowledge of GMPs, NIH, ICH guidelines, and FDA regulatory requirements.

Responsibilities

• Lead and empower QC team to ensure data integrity and on-time testing.
• Provide guidance to supervisors and analysts in the Quality Control Laboratory.
• Represent QC on projects and regulatory filings while ensuring compliance.
• Oversee investigations and ensure records and data are well documented.

Skills

Team leadership

GMP compliance

Analytical chemistry

Biopharmaceuticals

Communication skills

Education

Bachelor's degree in science

Job description

Samsung Biologics is seeking a senior QC leader to guide a cGMP Quality Control laboratory supporting manufacturing and development activities. You will lead a team of lab leaders and analysts, providing technical guidance and ensuring ALCOA data integrity across sampling, testing, and data review.

Responsibilities include ensuring regulatory compliance (FDA/ICH/GMP), coordinating investigations, mentoring staff, and representing QC on cross-functional projects while supporting regulatory