Director, Sterility Assurance & Contamination Control

Biopharma Asia; Raritan (NJ); On-site; USD 154,000 - 266,000; Full time

Benefits offered by this job

Vacation time

Sick leave

Holiday pay

Parental leave

Bereavement leave

Volunteer leave

Long-term incentive program

Job summary

Johnson & Johnson is currently recruiting a Director of Sterility Assurance at the Raritan, NJ site. This onsite role leads the sterility assurance and contamination control program, ensuring product quality, patient safety, and inspection readiness across cell therapy manufacturing.

You will oversee environmental monitoring, testing, investigations, CAPAs, and regulatory interactions while guiding a high-performing team and collaborating with global quality, manufacturing, and facilities groups.

Qualifications

• Bachelor’s degree in microbiology, pharmacy, engineering, chemistry or a related scientific / engineering discipline required; an advanced degree (MS/PHD) preferred
• Minimum of 10 years of relevant experience in the pharmaceutical or biopharmaceutical industry, including Quality Assurance, Quality Systems, sterility assurance, contamination control, or microbiological quality oversight in a manufacturing environment
• Minimum of 6 years of people-management experience, with demonstrated success building, developing, and retaining high-performing teams
• Proven experience in quality leadership roles supporting commercial cGMP manufacturing operations

Responsibilities

• Own the Raritan sterility assurance and contamination control program, serving as the primary site point of contact, subject matter expert, and decision-maker for related matters
• Develop, implement, maintain, and continuously improve the site contamination control strategy, addressing viral, bacterial, fungal, mycoplasma, endotoxin, and other adventitious-agent risks
• Provide governance and oversight for microbiological and virological control programs, including environmental monitoring, incoming-material testing, in-process testing, lot-release testing, and stability testing
• Lead site risk assessments, gap assessments, mitigation plans, and sustainable remediation activities related to aseptic processing, biological contamination control, and sterility assurance
• Provide strategic input to facility and equipment design, process design, material and personnel flows, cleaning and disinfection, segregation controls, maintenance, environmental monitoring, and microbiological testing
• Lead the quality response to contamination events, sterility failures, microbiological excursions, and adverse trends; ensure scientifically sound investigations, root-cause analysis, and effective CAPAs
• Review aseptic-processing and sterility-assurance performance indicators and trends; ensure timely, risk-based action plans and clear reporting to site and senior leadership
• Support regulatory inspections, internal audits, mock inspections, due-diligence activities, and other compliance initiatives as the site sterility assurance SME
• Monitor evolving regulatory requirements, industry expectations, and emerging technologies; translate relevant developments into timely, compliant, and practical site actions
• Coach and train employees to strengthen understanding of biological risks, contamination control, good aseptic practices, and expected behaviors
• Promote cross-site learning, capture lessons learned and near misses, and sponsor harmonization and continuous-improvement initiatives across the Advanced Therapies network
• Represent Raritan in network teams, governance forums, and appropriate external industry forums related to sterility assurance and contamination control, including implementation of applicable EU GMP Annex 1 requirements

Skills

Sterility assurance

Microbiology

Contamination control

Quality leadership

Regulatory inspections

Risk assessment

CAPA

Cross-functional leadership

Education

Bachelor's in microbiology/engineering/chemistry

MS/PHD preferred

Job description

Johnson & Johnson is currently recruiting a Director of Sterility Assurance at the Raritan, NJ site. This onsite role leads the sterility assurance and contamination control program, ensuring product quality, patient safety, and inspection readiness across cell therapy manufacturing.

You will oversee environmental monitoring, testing, investigations, CAPAs, and regulatory interactions while guiding a high-performing team and collaborating with global quality, manufacturing, and facilities groups.