Director of Sterility Assurance
Johnson & Johnson Innovative Medicine
Raritan, NJOnsitePosted 1 day ago$154,000.00 - $265,650.00
Full TimeDirector & AboveQuality (QA / QC)Pharmaceutical
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.
Job description
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.
Requirements
- Bachelor’s degree in microbiology, pharmacy, engineering, chemistry or a related scientific / engineering discipline required
- 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
- 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
Benefits
- Pension
- 401(k) Matching
- Long-term Incentive Program
- Vacation
- Sick Time
- Holiday Pay
- Floating Holidays
- Parental Leave
- Bereavement Leave
- Caregiver Leave
- Volunteer Leave
- Military Spouse Time-Off
Company overview
Johnson & Johnson Innovative Medicine is the pharmaceutical division of Johnson & Johnson, leading the way in medical innovation with a relentless focus on bringing transformational treatments to patients worldwide. The company applies rigorous science and compassion to address the most complex diseases of our time, developing groundbreaking medicines across key therapeutic areas including oncology, immunology, neuroscience, and cardiopulmonary medicine. With deep expertise and global reach, Johnson & Johnson Innovative Medicine reimagines how devastating diseases are treated and cured, delivering hope and better care for millions of patients and their families. The organization pioneers the path from laboratory research to clinical application, championing patients every step of the way while maintaining an unwavering commitment to scientific excellence and patient-centered innovation.