Senior QC Director — Biologics & Advanced Therapies

6014-Janssen Biotech, Inc. Legal Entity; Malvern (Chester County); On-site; USD 150,000 - 200,000; Full time

Job summary

Johnson & Johnson seeks an Associate Director, Quality Control to lead QC operations across Malvern and Spring House. This role oversees testing strategy, method lifecycle, data review, investigations, and capacity for biologics and advanced therapies.

You will manage 80+ staff and ensure inspection readiness, quality, and supply continuity. You will partner with Manufacturing, QA, Analytical Development, Regulatory, and external labs to maintain product quality and patient safety in a complex,

Qualifications

• Bachelor’s degree in biology, biochemistry, microbiology, chemistry, biotechnology, engineering or a related field.
• 10+ years of relevant, progressive experience in pharma/biotech QC with GMP labs.
• Minimum of five years of direct people-management experience, managing 80+ employees and contractors.
• Strong experience with biologics/biotherapeutics and cell/gene therapy testing.

Responsibilities

• Provide strategic, multi-site QC leadership for Malvern and Spring House laboratories.
• Ensure compliant, reliable testing across identity, purity, potency, safety, and related assays.
• Maintain data integrity and inspection readiness of laboratory systems and CAPA processes.
• Collaborate with Manufacturing, QA, Regulatory, and external labs to protect product quality and supply continuity.

Skills

People leadership

Quality compliance

Cross-functional collaboration

Laboratory oversight

cGMP knowledge

Education

Bachelor’s degree in biology/biochem/chemistry/biotech/engineering

Advanced degree preferred

Tools

eLIMS

Empower

Job description

Johnson & Johnson seeks an Associate Director, Quality Control to lead QC operations across Malvern and Spring House. This role oversees testing strategy, method lifecycle, data review, investigations, and capacity for biologics and advanced therapies.

You will manage 80+ staff and ensure inspection readiness, quality, and supply continuity. You will partner with Manufacturing, QA, Analytical Development, Regulatory, and external labs to maintain product quality and patient safety in a complex,