Director of Sterility Assurance

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.

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, 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.

Title Associate Director, Process & Digital

Req ID R-105948

Recruiter

Kaia Phoenix-Lloyd

Hiring Manager

derek lamonde

Primary Req Location

US063 NJ Raritan - 920 US Hwy 202, Raritan, New Jersey, United States

Additional Req Locations

Horsham, Pennsylvania, United States of America, Horsham, Pennsylvania, United States

New Brunswick, New Jersey, United States of America, New Brunswick, New Jersey, United States

Somerville, New Jersey, United States of America, Somerville, New Jersey, United States

Wayne, Pennsylvania, United States of America, Wayne, Pennsylvania, United States

Titusville, New Jersey, United States of America, Titusville, New Jersey, United States

Malvern, Pennsylvania, United States of America, Malvern, Pennsylvania, United States

Number of Openings 1

Recruiting Start Date 10/19/2026

Job Level 31

Position Description

Johnson & Johnson is currently recruiting for a Associate Director, Process Optimization & Digital Operations! This position can be located in New Jersey, Pennsylvania, Zug Switzerland, High Wycombe, UK, Issy-Les France & Beerse, Belgium.
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
North America- Requisition #R-105948
EMEA– Requisition#R-106959
Position Summary
The Associate Director, Process Optimization & Digital Operations supports Clinical Risk Management Operational Excellence by coordinating process optimization and the day-to-day administration of the CRM digital landscape. The role enables consistent operation, user engagement, controlled change, vendor delivery, and audit or inspection readiness across CRM tools and related services. The Associate Director supports CRM leadership by translating approved strategy and governance direction into practical operating routines, documentation, communications, reporting, and follow-through.
This role serves as the operational point of contact for CRM super-user forums, vendor coordination, digital asset administration, taxonomy and metadata stewardship, portal support, governance logistics, escalation intake, and evidence coordination for audits and inspections. The role identifies improvement opportunities and implements approved enhancements, while strategic ownership, investment decisions, enterprise alignment, and portfolio direction remain with the CRM leadership.
Major Duties & Responsibilities
25%
Process optimization and operational improvement: Map current-state activities, identify administrative and workflow inefficiencies, facilitate root-cause analysis, coordinate approved improvements, maintain action plans, and monitor adoption and effectiveness.
20%
Digital landscape administration and user support: Coordinate operational administration for CRM-owned tools and services, maintain support routines and user guidance, triage business questions, route technical issues, and support release readiness and communications.
15%
Super-user forums and stakeholder enablement: Plan and facilitate super-user forums, maintain agendas and decision or action logs, gather feedback, coordinate demonstrations and learning materials, and help user communities adopt approved changes.
15%
Vendor and service coordination: Serve as the day-to-day CRM contact for vendors, contractors, and service providers; coordinate deliverables, meetings, access, documentation, invoices or forecasts as applicable, risks, issues, and escalation to the Associate Director.
10%
Audit and inspection support: Coordinate collection, organization, and quality review of system, process, training, governance, and vendor evidence; maintain readiness materials; track requests and actions; and support timely responses under CRM quality leadership.
10%
Governance, escalation, portal, and taxonomy support: Administer governance calendars, intake and escalation logs, decision records, and follow-up. Maintain CRM portal content and act as the operational point for taxonomy, metadata, naming conventions, and controlled content organization.
5%
Metrics and management reporting: Compile operational measures, service trends, adoption feedback, action status, and improvement outcomes for review by the CRM OpEx Leadership and relevant governance forums.
Role Boundaries and Decision Rights
- Executes within approved CRM digital strategy, governance, standards, budgets, and roadmaps; does not independently set enterprise digital strategy or investment priorities.
- Recommends process, content, taxonomy, support, and service improvements; escalates material quality, compliance, budget, resource, architecture, or cross-functional decisions to the Associate Director.
- Coordinates vendors and service delivery at the operational level; the Associate Director retains portfolio-level accountability, strategic supplier direction, and major commercial or resource decisions.
- Supports governance administration and implementation; the Associate Director retains accountability for governance design, strategic prioritization, and senior cross-functional alignment.
Qualifications
Education:
A minimum of a Bachelor's or equivalent University degree is required with a focus in life sciences, quality, technology, data, engineering, business, or a related discipline preferred.
Skills & Capabilities:
- Relevant experience in pharmaceutical, medical device, healthcare, technology, consulting, or another regulated environment.
- Experience supporting process improvement, digital operations, business systems, communities of practice or super-user networks, vendors, document or portal administration, or audit and inspection readiness.
- Working knowledge of quality systems, controlled documentation, data and metadata concepts, and change management; familiarity with GxP or R&D Quality environments is preferred.
- Strong organization, facilitation, communication, stakeholder coordination, problem-solving, and attention to detail.
- Ability to manage multiple priorities, maintain accurate action and decision records, and escalate issues with clear options and recommendations.
- Proficiency with Microsoft Office, collaboration platforms, reporting tools, and business workflow or ticketing tools.

Key Working Relationships
- Internal: CRM process owners and subject matter experts, CRM-OpEx, RDQ partners, Quality, Technology, Procurement, Finance, and digital product or service teams.
- External: Technology and service vendors, consultants, contractors, and extended workforce partners supporting CRM operations.
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.

Required Skills:

Preferred Skills:

The anticipated base pay range for this position is :
$154,000.00 - $265,650.00

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