Director of Sterility Assurance

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Job Function:
Quality

Job Sub Function:
Quality Assurance

Job Category:
People Leader

All Job Posting Locations:
Raritan, New Jersey, United States of America

Job Description:

Johnson & Johnson is currently recruiting for a Director of Sterility Assurance! This position will be performed fully onsite in Raritan, NJ.

Position Summary

The Director of Sterility Assurance, Cell Therapy Operations, provides site-level leadership and strategic direction for microbiological and virological control across cell therapy and lentiviral manufacturing at the Raritan facility.

The role is accountable for establishing and sustaining an effective contamination control and sterility assurance program that protects product quality and patient safety, supports reliable operations, and maintains inspection readiness.

The Director serves as the site's primary subject matter expert and decision-maker for sterility assurance and contamination control and partners with Site and Global Quality, Manufacturing, Quality Control, Facilities and Engineering, MSAT, and Global Sterility Assurance/MQSA to align site practices with applicable health authority requirements, industry expectations, and scientific principles.

Major Duties
Site Sterility Assurance and Contamination Control Leadership



* 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, ...