Director of Sterility Assurance

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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, 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 corrective and preventive actions (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.

Leadership Team and People Management

• Set functional priorities, objectives, and performance measures aligned with site and enterprise strategy, Our Credo, and applicable leadership principles.

• Build and lead a high-performing, collaborative Sterility Assurance team through effective organization design, hiring, coaching, capability building, performance management, talent development, and succession planning.

• Establish strong partnerships with Site Leadership, Manufacturing, Quality Control, Facilities and Engineering, MSAT, Supply Chain, Process Development, Analytical Development, Product Quality Management, and Global Quality organizations.

• Coordinate quality activities across functions and sites to enable integrated, efficient, and compliant business processes.

• Collaborate with Advanced Therapies Quality Leadership Team members to drive alignment, standardization, lifecycle management of GMP policies, and continuous improvement of the Quality Management System.

• Represent Raritan in the planning, development, and execution of corporate Quality initiatives and provide input to resource and budget planning.

Qualifications

Education:

Bachelor’s degree in microbiology, pharmacy, engineering, chemistry or a related scientific / engineering discipline required; an advanced degree (MS/PHD) preferred

Required Years of Related Experience:

• 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.

Required Knowledge, Skills and Abilities:

• Expert knowledge of sterility assurance, contamination control, microbiology, and aseptic processing principles as applied to biological and cell therapy manufacturing.

• Strong working knowledge of applicable cGMP regulations and guidance, including US FDA and European Union expectations and EU GMP Annex 1.

• Demonstrated ability to develop and implement risk-based sterility assurance strategies that support product quality, patient safety, operational reliability, and inspection readiness.

• Experience leading responses to contamination events, microbiological excursions, sterility failures, and adverse trends, including investigations, root-cause analysis, and CAPA effectiveness.

• Experience hosting or supporting global health authority inspections and presenting product, process, and quality-system information to regulatory reviewers.

• Experience overseeing cGMP operations in a commercial manufacturing facility; experience with aseptic processing in ISO 5 environments and biosafety cabinets is strongly preferred.

• Ability to influence across functions and organizational levels, communicate complex scientific and compliance topics clearly, and make balanced, risk-based decisions.

• Strategic thinking, sound judgment, effective negotiation and conflict-resolution skills, and a strong continuous-improvement mindset.

• Business acumen, including resource and budget planning.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource.

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For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits