Director, Sterility Assurance & Contamination Control

6062-Janssen Pharmaceuticals, Inc. Legal Entity; Raritan (NJ); On-site; USD 154,000 - 266,000; Full time

Benefits offered by this job

Vacation –120 hours per calendar year

Parental Leave – 480 hours within one 

Job summary

Johnson & Johnson in Raritan, NJ seeks a Director of Sterility Assurance to lead site-wide programs for microbiological and virological control across cell therapy operations. This onsite leadership role requires directing contamination control, risk assessments and CAPA, while aligning with global Quality, Manufacturing and regulatory expectations.

The ideal candidate has 10+ years in pharma/biopharma quality, with 6+ years in people management and deep expertise in aseptic processing,

Qualifications

• Expert knowledge of sterility assurance and contamination control in biopharma.
• Strong understanding of cGMP regulations (FDA/EU) and quality systems.
• Experience leading investigations, CAPA and regulatory inspections.

Responsibilities

• Own the site sterility assurance program and act as SME for contamination control.
• Lead risk assessments, investigations, CAPA and remediation activities.
• Support regulatory inspections and internal audits; train staff on aseptic practices.
• Collaborate with Quality, Manufacturing, MSAT and Global Quality for alignment.

Skills

Sterility assurance

Contamination control

Microbiology

Aseptic processing

Regulatory knowledge

Leadership

Strategic thinking

Education

Bachelor’s degree in microbiology, pharmacy, engineering, chemistry or related

Job description

Johnson & Johnson in Raritan, NJ seeks a Director of Sterility Assurance to lead site-wide programs for microbiological and virological control across cell therapy operations. This onsite leadership role requires directing contamination control, risk assessments and CAPA, while aligning with global Quality, Manufacturing and regulatory expectations.

The ideal candidate has 10+ years in pharma/biopharma quality, with 6+ years in people management and deep expertise in aseptic processing,