Senior QC Leader, Biologics & Advanced Therapies

6014-Janssen Biotech, Inc. Legal Entity; Malvern (Chester County); On-site; USD 150,000 - 190,000; Full time

Job summary

Johnson & Johnson, based in Malvern, PA, leads the Quality Control function across two sites for biotherapeutics and advanced therapies. The Senior Manager QC directs strategy and staffing to ensure robust testing and high-quality results.

The role oversees 80+ professionals, delivers compliant testing, data review, and timely reporting, and partners with Manufacturing, QA, Regulatory, and external labs to protect product quality and patient safety.

Qualifications

• Bachelor's degree in biology, biochemistry, microbiology, chemistry, biotechnology, or related field.
• 10+ years in pharma/biotech with quality control exposure.
• 5+ years of direct people-management experience.
• Experience with biologics or advanced therapies preferred.
• Strong knowledge of cGMP, FDA/EMA/ICH guidelines.

Responsibilities

• Lead a multi-site QC organization of 80+ staff and contractors.
• Oversee QC testing labs for biologics and advanced therapies.
• Ensure compliant testing, data review, and timely reporting.
• Maintain inspection readiness and drive continuous improvement.
• Collaborate with manufacturing, QA, regulatory and external labs.

Skills

People leadership

QC oversight

Cross-functional collaboration

Regulatory compliance

Quality systems

Education

Bachelor's degree in biology/biochemistry/chemistry/biotechnology/engineering

Tools

eLIMS

Empower

Job description

Johnson & Johnson, based in Malvern, PA, leads the Quality Control function across two sites for biotherapeutics and advanced therapies. The Senior Manager QC directs strategy and staffing to ensure robust testing and high-quality results.

The role oversees 80+ professionals, delivers compliant testing, data review, and timely reporting, and partners with Manufacturing, QA, Regulatory, and external labs to protect product quality and patient safety.