Senior QC Leader - Biologics & Multi-Site Labs

Johnson & Johnson Innovative Medicine; Malvern (AR); On-site; USD 180,000 - 240,000; Full time

Job summary

Johnson & Johnson Innovative Medicine in Malvern, PA, seeks a Senior Manager, Quality Control to lead a multi-site QC organization of 80+ employees and contractors. You will oversee testing strategies, data integrity, and regulatory readiness, ensuring product quality and patient safety across biologics programs.

This role requires strong leadership, cGMP expertise, and cross-functional partnership with Manufacturing, QA, Analytical Development, and Regulatory to deliver inspection-ready

Qualifications

• Bachelor’s degree in biology, biochemistry, microbiology, chemistry, biotechnology, engineering, or related discipline.
• Minimum of 10 years in pharma/biotech with GMP QC experience.
• Minimum of five years in people-management of large teams.
• Experience with biologics or advanced therapies preferred.
• Knowledge of FDA/EMA/ICH and global cGMP expectations.

Responsibilities

• Lead multi-site QC organization of 80+ employees and contractors.
• Set vision, operating model, goals, and workforce strategy for Malvern & Spring House.
• Oversee QC testing, sample management, and equipment lifecycle.
• Ensure data integrity, investigations, CAPAs, and compliant reporting.
• Serve as senior QC representative during inspections and audits.

Skills

People leadership

Quality systems

GxP / cGMP

Biologics testing

Regulatory knowledge

Cross-site leadership

Education

Bachelor’s degree in life sciences

Advanced degree preferred

Tools

eLIMS

Empower

Laboratory instrumentation lifecycle

Job description

Johnson & Johnson Innovative Medicine in Malvern, PA, seeks a Senior Manager, Quality Control to lead a multi-site QC organization of 80+ employees and contractors. You will oversee testing strategies, data integrity, and regulatory readiness, ensuring product quality and patient safety across biologics programs.

This role requires strong leadership, cGMP expertise, and cross-functional partnership with Manufacturing, QA, Analytical Development, and Regulatory to deliver inspection-ready