Senior QC Leader, Biologics & Advanced Therapies

Regulatory Jobs; Pennsylvania; On-site; USD 150,000 - 190,000; Full time

Job summary

Johnson & Johnson is seeking a Senior Manager, Quality Control to lead a multi-site QC organization across Malvern and Spring House in Pennsylvania. You will oversee testing laboratories supporting biotherapeutic and advanced therapies, ensuring compliant, timely, and high-quality results and inspection readiness.

Reporting to the Site Quality Head, you will shape the QC strategy, develop leaders, drive continuous improvement, and partner with Manufacturing, QA, Analytical Development, and

Qualifications

• Bachelor’s degree in biology, biochemistry, microbiology, chemistry, biotechnology, engineering, or related field required.
• Minimum of 10 years of relevant experience in pharmaceutical/biotechnology with GMP QC laboratories.
• Minimum of five years of direct people-management experience.
• Strong experience with biologics/biotherapeutics and advanced therapies testing.
• Solid knowledge of FDA, EMA, ICH, pharmacopeial and global cGMP expectations.

Responsibilities

• Lead, develop, and retain a multi-site QC organization of 80+ employees and contractors.
• Define and execute the QC strategy, staffing, and operating model for two sites.
• Ensure compliant, timely sampling, testing, review, approval, and reporting across materials and products.
• Oversee method development, qualification, validation, transfer and verification activities.
• Maintain inspection readiness and lead during health authority inspections.

Skills

People leadership

Cross-functional collaboration

Quality systems

Regulatory knowledge

Education

Bachelor’s degree in biology/related field

Job description

Johnson & Johnson is seeking a Senior Manager, Quality Control to lead a multi-site QC organization across Malvern and Spring House in Pennsylvania. You will oversee testing laboratories supporting biotherapeutic and advanced therapies, ensuring compliant, timely, and high-quality results and inspection readiness.

Reporting to the Site Quality Head, you will shape the QC strategy, develop leaders, drive continuous improvement, and partner with Manufacturing, QA, Analytical Development, and