Director of Sterility Assurance

Johnson & Johnson•Raritan, NJ

3d•Onsite

About The Position

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.

Requirements

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.
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)

Nice To Haves

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

Responsibilities

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 standards
Deliver 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.
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.

Benefits

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