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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 https://www.jnj.com

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 Director of Sterility Assurance! This position will be located in Raritan, NJ.

Position Summary:

The Director of Sterility Assurance is a leadership role responsible for overseeing all microbiological and virological control aspects of cell and gene therapy product manufacturing at the Raritan facility. This role ensures the safety, quality, and compliance of our products and processes through the development, implementation, and management of robust testing programs, risk assessments, and quality systems. The Director will provide technical expertise and strategic direction in microbiology and virology.

The candidate will consult with JNJ manufacturing facilities, Global and Site Quality and Global Sterility Assurance and other functions to educate on the Sterility Assurance program requirements and proactively ensure compliance of the JNJ Sterility Assurance program with various country agency standards, industry trends and scientific principles.

Key Responsibilities:

_Raritan Site Quality Management Responsibilities (80%)_

+ Develop, and maintain oversight of comprehensive microbiology and virology programs, including environmental monitoring, incoming material testing, in-process testing, lot release testing, and stability testing.

+ Serves as primary point of contact and decision maker for internal policies, procedures, and strategy documents governing Sterility Assurance and Contamination Control related topics.

+ Support in knowledge advancement beyond the Quality organization to build, maintain, and develop capabilities across the JNJ network for the Sterility Assurance space. Development of knowledge-based programs to advance company education and training programs.

+ Provide mentoring leadership to stakeholder SMEs to build capability for new and existing sites or where gaps in technical expertise have been identified.Sponsor and oversee activities focused on driving process improvements and harmonization projects across the JNJ network for Sterility Assurance and Contamination Control.

+ Serve as the SME leadership role for topics associated with Sterility Assurance and Contamination Control across the network, representing on network teams and other appropriate governance forums.

+ Provide technical support to during new process design and facility change activities to ensure Sterility Assurance programs and product requirements are supported at the sites.Engage in providing support during regulatory submissions and on-site inspections. Define and execute the process for managing observations and commitments related to Sterility Assurance for the Raritan.

+ Accountable for transformation of sterility assurance global standards across Engineering, MSAT and Quality and ensuring that they are in use across all sites.

+ Set vision for the future to proactively meet regulatory expectations.

+ Accountable for program management for execution / implementation to global standardsDeliver Annex 1 compliance through standardized global policies.

+ Implement KPI dashboards for contamination control.

+ Define clear project and governance frameworks to clarify roles and responsibilities between global and local teams.

+ Drive continuous improvement and proactive inspection readiness with storyboard creation and coaching/mentoring.

+ Lead the uplift in capability building and leadership development across functions.

+ External network/advocacy with industry forums and regulators to keep pace with evolving regulatory expectations and emerging technology.

_Leadership Team Responsibilities (20%)_

+ Sets and manages targets and objectives for the Raritan site ensuring alignment with overall company strategy.

+ Drives the achievement of annual goals, guided by Our Credo and leadership principles.

+ Builds and sustains strong relationships with internal and external stakeholders, including Global Quality teams, Manufacturing, Quality Control, Facilities and Engineering, and partners.

+ Coordinates quality-related activities across departments, sites, and organizations to proactively support and optimize business processes.

+ Ensure the Sterility Assurance department has a clear organizational structure, with robust formation and succession plans to support long-term stability.

+ Provides leadership to build a high-performing, collaborative team through hiring, mentoring, and talent development.

+ Champions a culture of quality compliance, diversity, inclusion, and continuous improvement.

+ Manages professionals within the Quality team, fostering ongoing talent development and succession planning.

+ Collaborates with the VP, IMSC Quality, and other site Quality Heads as part of the Advanced Therapies Quality Leadership Team (ATQLT) to ensure harmonization and standardization across sites.

+ Partners with cross-functional leaders to support continuous improvement and lifecycle management of GMP policies and the QMS.

+ Represents Raritan in the planning, development, and execution of corporate Quality initiatives.

+ Establishes effective partnerships across business units, sites, and functions to ensure integrated and efficient business processes.

Qualifications:

Education:

A minimum of a Bachelors or equivalent University degree is required with a focus in pharmacy, engineering, chemistry, microbiology or related scientific / engineering discipline preferred. Masters or advanced degree preferred.

Required:

+ Minimum of 10 years of Quality Assurance / Quality Systems experience related to manufacturing

+ Comprehensive knowledge of vaccines, biological manufacturing and related Quality management processes and systems

+ Proven people management and Quality leadership experience

+ Strong people leadership skills and a proven track record in attracting, developing and retaining talent in the organization

+ Comprehensive regulatory cGMP and technical knowledge to develop sterility assurance strategies necessary to maintain the desired level of inspection readiness

+ Experience hosting global regulatory agency inspections and successfully presenting product and quality compliance programs to regulatory reviewers

+ Experience with implementing and overseeing cGMP operations in a commercial manufacturing facility

+ Demonstrated experience building and leading exceptional Quality Assurance, Quality Systems and Quality Control teams

+ Extensive knowledge of chemical, biochemical and microbiological concepts

+ Knowledge of cGMP regulations and FDA/EU guidance

+ Fluent in English (written and spoken)

Preferred:

+ Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is highly preferred

+ Strategic thinking with the ability to manage/master complexity and to act as a sponsor for change

+ Ability to prioritize and guide the organization in coping with the demands of a rapidly changing environment

+ Ability to apply appropriate risk assessment strategies to manage business & compliance priorities

+ Effective negotiation and influencing skills and lead with a mindset of continuous improvement

+ Balanced decision-making skills and ability to effectively resolve conflict, when needed

+ Business acumen; develop and control budgets

+ Ability to communicate effectively with different levels in the organization and with health authorities

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:

Aseptic Processing, Clean Room Manufacturing, Contamination Control, Risk Assessments

The anticipated base pay range for this position is :

$150,000.00 - $258,750.00

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