Johnson & Johnson Consumer, Inc. is recruiting for a SENIOR MANAGER, FRANCHISE QUALITY - PRODUCT LIFECYCLE MANAGEMENT (PLM) for the Skin Health Franchise to be located in Skillman, NJ or Fort Washington, PA. JOHNSON & JOHNSON CONSUMER INC., based in Skillman, N.J., is one of the world's largest consumer health and personal care products company. Our consumer companies produce many of the world's most trusted brands, among them JOHNSON'S® Baby, BAND-AID®, NEUTROGENA®, TYLENOL®, MOTRIN®, and LISTERINE®. Each one of our consumer businesses embraces innovative science to create products that anticipate consumer needs and create experiences that help them live healthy, vibrant lives. Johnson & Johnson announced plans to separate our Consumer Health business to create a new publicly traded company. The process of the planned separation is anticipated to be completed within 24 months, and it will be subject to legal requirements including consultation with works councils and other employee representative bodies, as required, and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of a new entity within New Consumer Health and your employment would be governed by New Consumer Health's employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by New Consumer Health at an appropriate time and subject to any necessary consultation processes. The SENIOR MANAGER, FRANCHISE QUALITY - PRODUCT LIFECYCLE MANAGEMENT (PLM) will serve as the end-to-end quality owner of Skin Health products with responsibility for product quality and compliance pre-launch and post-launch.

• Develops, establishes and maintains processes and controls ensuring that the performance and quality of new and reformulated/re-designed products conform to established standards including policies, procedures, U.S. and Global Quality Systems Regulations and current Good Manufacturing Practices (cGMPs).
• Partners with Product Development, Technical Transfer and Manufacturing functions to define the product and process Critical-to-Quality (CTQ) / Critical Process Parameters (CPPs).
• Reviews and approves the Development Plan (DP) for new product introductions and product changes requiring an APR or Global Change Control (GCC) to ensure that all work has been conducted according to the DP, established procedures and regulatory requirements.
• Partners with the Raw Material Center to ensure that all new raw materials are qualified and suppliers have been approved in accordance with compliance requirements.
• Responsible for the final coordination and flawless execution of new product activities between R&D, Franchise Quality, MAKE Quality, Operations and Supply Chain, including, high quality documentation for Approval for Product Release (APR).
• Partners with Internal and External Manufacturing QA and Supplier Quality on the transfer of new products and processes to the manufacturing environment establishing clear quality plans and robust process capabilities.
• Provides ongoing mentoring and coaching of team members. Ensures staff are trained on procedures and systems associated with their assigned tasks. Performs administrative and talent management related tasks.
• Guides and trains project teams to build in strategic compliance and ensure quality requirements are met during product development, scale up and validation.
• Educates and empowers business partners to understand quality system requirements and how they impact product quality and regulatory compliance.
• Leads and/or participates in product and process risk assessments.
• Serves as a Quality representative on New Product Innovation (NPI) Teams to ensure timely execution of development initiatives.
• Provides Quality guidance during Technical Review Forums (TRF) by ensuring that data from all functions is reviewed by a cross-functional team and that potential concerns are addressed prior to production or commercialization.
• Represents Franchise Quality in innovation forums to ensure that quality and compliance is addressed during the deployment of new product prior to Commit-to-Trade (CTT).
• Assists in the review of Complaint Vigilance Review Board (CVRB) data in preparation for the CVRB meetings. Highlights any implications to the business identified during the review process.
• Leads, develops and implements new policies, standards and guidance for new technologies, new businesses and emerging regulations.
• Reviews product specifications to ensure that design criteria can be met post launch and over the entire shelf life or design life of the product.
• Ensures that Corrective Actions/Preventive Actions (CAPAs) are initiated, assigned, thoroughly investigated, documented and effectively resolved when deficiencies are found during development, testing, manufacturing and in the APR document.
• Measure and evaluate performance of the new product commercialization process.
• Partners with R&D Life Cycle Management, EM/MAKE Q&C, Regulatory Affairs, and Medical Safety to ensure that significant quality issues are appropriately escalated and addressed via PAM and QRB meetings as needed.
• Support and/or provide guidance and oversight for acquisitions; including business integration and improvement of quality system compliance if required.
• Serve as back-up to the Regional Franchise Quality Leader at various governance and franchise forums.
• Participate in ad hoc special project, process improvement, and innovation teams as needed.

GENERAL SKILLS:

• Problem solver and proactive strategic thinker
• Strong leader and cross-functional collaborator
• Role model with high commitment to quality
• Flexible and persistent
• Ability to influence without authority, overcome challenges, and effectively negotiate with colleagues across levels and functions
• Ability to independently plan, organize, co-ordinate, run and complete assigned tasks
• Excellent communicator with outstanding interpersonal skills and tact
• Ability to allocate and balance resources across challenging priorities; find opportunities and solutions, and mentor others to do the same.
• Ability to provide guidance, collaborate, and effectively coach and develop teams to ensure an ongoing state of compliance.
• Ability to negotiate, influence and lead with and without direct line authority, and to engage others
• Ability to work and make compliance decisions independently and on multiple projects.

QUALIFICATIONS REQUIRED:

• University/Bachelors Degree or Equivalent in related field
• Minimum of 8 years of relative business experience in an FDA (or Health Canada) regulated industry
• Minimum of 5 years of Quality experience in an FDA (or Health Canada) regulated environment
• Minimum of 3 years of experience in a People Leader/Management role
• Experience in Quality Assurance, Quality Systems, and/or New Product Development
• Experience with applicable regulatory requirements (cGMPs) governing various product classification types (Cosmetic, OTC/OTC Monograph and Medical Devices)
• Experience leading complex and/or strategic projects
• This position will be located in Skillman, NJ or Fort Washington, PA and may require up to 10% domestic & international travel

PREFERRED:

• Other advanced degree
• ASQ and/or Project Management certifications
• Experience in technical transfer, process development, analytical chemistry, microbiology, product safety, and process validation
• Experience conducting or hosting audits
• Continuous improvement experience and/or approach

OTHER: The anticipated base pay range in New Jersey for this position is 113,000 to 170,000. At Johnson & Johnson, we're on a mission to change the trajectory of health for humanity. That starts by creating the world's healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability. PRIMARY LOCATION United States-New Jersey-Skillman-199 Grandview Road OTHER LOCATIONS North America-United States-Pennsylvania-Fort Washington ORGANIZATION Johnson & Johnson Consumer Inc. (6101) JOB FUNCTION Quality REQUISITION ID 2206091894W

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