New · posted Nov 12
Johnson & Johnson · Biotechnology
Director of Sterility Assurance
- Raritan, NJ
- On-site
- Full-time
- Director
The role
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.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Johnson & Johnson is currently recruiting for a Director of Sterility Assurance! This position will be performed fully onsite in Raritan, NJ.
What you need
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.
What you'll do
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.
Pay and benefits
$154,000 – $265,650 a year
Employer providedThe anticipated base pay range for this position is
$154,000.00 - $265,650.00
Pension and 401(k) savings plan
Long-term incentive program
Vacation (120 hours per year)
Sick time
13 paid holidays per year
Parental leave (480 hours)
Where you'll work
Raritan, NJOn-siteOpen in Maps (opens in a new tab)
More jobs in Raritan, NJWorking conditions
Job Function
Quality
Job Sub Function
Quality Assurance
Job Category
People Leader
All Job Posting Locations
Raritan, New Jersey, United States of America
Equal opportunity, accessibility and legal noticesJohnson & Johnson's statements, word for word
Additional Description for Pay Transparency
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits
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.
Job intelligence
The context around this role
Live data · November 12, 2026
Salary intelligence
How the pay compares
This role's midpoint is 3% above the US median for Microbiology & Sterility Assurance roles at this level.
This roleEmployer provided
Director roles in the US5 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $154,000 | — | $265,650 |
| All US (middle half) | $195,000 | $204,500 | $210,000 |
This role: Johnson & Johnson's own published range. Comparisons: the base pay employers published on open Microbiology & Sterility Assurance roles at the same level on Regulatory Jobs, November 12, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Microbiology & Sterility Assurance
The general path across 58 open Microbiology & Sterility Assurance roles on Regulatory Jobs, with the titles they carry most. Not Johnson & Johnson's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 35 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership13
- GMP and compliance10
- Lab testing and methods10
- Quality systems and risk3
- Investigations and CAPA2
- Regulatory submissions2
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Microbiology & Sterility Assurance work in biotechnology, led by the two this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticalsNamed in the posting
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validationNamed in the posting
- FDAFDA aseptic processing guidance(official source, opens in a new tab)Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practice
- USPUSP–NF(official source, opens in a new tab)US Pharmacopeia general chapters and monographs, such as <61> bioburden, <85> endotoxin, <1225> validation
- ISOISO 14644-1(official source, opens in a new tab)Cleanroom air cleanliness classification by particle concentration
- ICHICH Q9(R1)(official source, opens in a new tab)Quality risk management
- FDA21 CFR Part 1271(official source, opens in a new tab)Human cells, tissues, and cellular and tissue-based products
- ICHICH Q10(official source, opens in a new tab)The pharmaceutical quality system across the product lifecycle
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- EDQMEuropean Pharmacopoeia(official source, opens in a new tab)The Ph. Eur. quality standards for medicines in Europe, published by the EDQM
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- FDA21 CFR Parts 600 to 680(official source, opens in a new tab)FDA standards for biological products, from licensing to lot release
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDAFDA process validation guidance(official source, opens in a new tab)Process Validation: General Principles and Practices
Company hiring pulse
Johnson & Johnson on Regulatory Jobs
- 42
- Open roles
- 42
- Distinct roles
- 17
- Locations
By discipline
- Quality25 60%
- Clinical9 21%
- Regulatory8 19%
By level
- Senior & Principal16 38%
- Manager15 36%
- Associate & Specialist6 14%
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Director of Sterility Assurance at Johnson & Johnson
Applications close November 21. $154K–$266K a year, employer provided.