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Job Information

J&J Family of Companies Quality Stability Manager in Skillman, New Jersey

Johnson & Johnson Consumer Inc is currently recruiting for a Quality Stability Manager to be located in Fort Washington, PA or Skillman, NJ.

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.

Summary

The Quality Stability Manager is responsible for developing and leading the implementation of functional strategies to manage the Stability program supporting commercial production, leading cross-functional compliance & quality improvement initiatives with respect to the Stability program, and reporting performance metrics related to the processes. This position has direct responsibility for a team of professional employees (Quality Analyst/Stability Associate) and contractors at multiple levels of experience, training, and skills. The Manager is expected to manage team member development, performance, and empowerment consistent with the goals and expectations of J&J Consumer Healthcare, the NA Quality MAKE and JJCI McNeil Consumer Healthcare Division organization.

See Section III, Responsibilities, for the detailed Stability Manager position description.

• Serve as the Chairperson to the Stability Committee and the owner of the Stability Community of Practice.

• Lead and support to the Marketed Product Stability groups at Consumer NA and Self Care sites for their Marketed Product Stability (MPS) programs including annual commitments and changes to existing products.

• Provide guidance and support to the Research & Development (R&D) Stability group for developmental stability programs on new products, technical transfers and change controls ensuring that expectations for market approval are incorporated into the stability strategies.

• Responsible for approving the development of stability strategies (for both the R&D and MPS groups) based on regulatory requirements, internal procedures, technical information and historical stability data.

• Facilitate execution of the established stability strategy across functional areas and across internal and external sites, including stability study initiation, stability sample management, stability storage and stability testing.

• Partner with cross functional peer groups and management in the planning and execution of project tasks within established timelines.

• Partners with External Manufacturers, External Packagers, and Contract Laboratories which manufacture and/or perform stability testing on behalf of J&J Consumer to ensure that requirements are being met.

• Approve documentation of Master Stability Protocols, Study Specific Stability Protocols, Stability Plans, Stability Reports, statistical analysis of stability data and the Annual Stability Report (used for both the Annual Product Review and the Annual Report submission to the FDA).

• Provide direction and leadership to stability personnel within the EM and IM Stability group.

• Provide detailed or summary communication to senior leadership on status of key initiatives and issues.

Responsibilities

• Ensure quality and compliance in all my actions by:

All employees

• Attend GMP training on the schedule designated for my role and as appropriate for my role

• Adhere to strict compliance with procedures applicable to my role.

• Exercise the highest level of integrity in the tasks that I perform

• In a timely and prompt manner, identify, report and seek correction for deviations noted in my workplace.

• Embrace a behavior of employee involvement and commitment to doing the job right the first time

People Managers

• Ensure employees under your scope of responsibility are trained in required procedures for the execution of their role and maintain current with training requirements during the year.

• Promote an environment of employee involvement in the workplace.

• Seek prompt identification, reporting and correction of deviations in the workplace as noted by employees.

Job Related Duties

• Provides overall Quality Assurance leadership for Stability.

• Maintain up to date knowledge of industry practices and compliance with cGMPs and ensure procedures are authored/revised in support of stability processes.

• Serve as the Chairperson to the Stability Committee and the owner of the Stability Community of Practice.

• Lead and support to the Marketed Product Stability groups at EM Consumer NA and Self Care sites for their Marketed Product Stability (MPS) programs including annual commitments and changes to existing products.

• Provide guidance and support to the Research & Development (R&D) Stability group for developmental stability programs on new products, technical transfers and change controls ensuring that expectations for market approval are incorporated into the stability strategies.

• Responsible for approving the development of stability strategies (for both the R&D and MPS groups) based on regulatory requirements, internal procedures, technical information and historical stability data.

• Facilitate execution of the established stability strategy across functional areas and across internal and external sites, including stability study initiation, stability sample management, stability storage and stability testing.

• Partner with cross functional peer groups and management in the planning and execution of project tasks within established timelines.

• Partners with External Manufacturers, External Packagers, and Contract Laboratories which manufacture and/or perform stability testing on behalf of J&J Consumer to ensure that requirements are being met.

• Ensure the creation, dissemination, approval, and completion of Master Stability Protocols, Study Specific Stability Protocols, Stability Schedules/Plans, Stability Reports, statistical analysis of stability data and the Annual Stability Report.

• Provide direction and leadership to stability personnel within the EM and IM Stability group.

• Oversee staff to ensure:

• Correct use of statistical tools for trend monitoring and evaluation of EM Stability data,

• Procedures for data receipt/verification and statistical output interpretation, documentation, and review are followed,

• Review and approval of compliance records, specifications, procedures, and other documents, as required by procedure,

• Stability databases are maintained as appropriate.

• Provide detailed or summary communication to senior leadership on status of key initiatives and issues.

Qualifications

• A minimum of a Bachelor’s Degree is required, with a focus in a technical field (Chemistry, Engineering, Sciences, Pharmacy or similar disciplines) preferred

• Masters or advanced degree is preferred

• A minimum of 8 years of relevant professional experience is required

• Experience in a Quality Assurance function is required

• Experience in a regulated industry is preferred (Pharmaceutical, Medical Device, OTC Drug, Cosmetic, cGMP requirements and/or Food and Dietary Supplements Industry)

• Experience in the design/execution of stability studies is required

• Experience in the facilitation of internal and external audits and regulatory inspections required

• People management/supervisory experience is preferred

• Demonstrated ability to lead cross-functional teams and collaborate with internal/external partners to enhance relationships and interactions, including interfacing with management to inform, drive change, and provide direct feedback is required

• Demonstrated ability to manage and lead complex or ambiguous issues autonomously is required

• Strong knowledge of 21 CFR 210 & 211 is required

• Strong knowledge of ICH and SUPAC guidance is required

• Results-oriented with strong track record of success in delivering on objectives.

• Theoretical and/or hands experience in applied analytical chemistry and related instrumentation such liquid and gas chromatography, FTIR/UV/Vis/NIR spectrometry and wet chemistry is preferred

• Knowledge of method transfer, and validation requirements is necessary is preferred

• This position is located in Fort Washington, PA or Skillman, NJ and may require travel up to 10% both internationally and domestically.

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-Pennsylvania-Fort Washington-

Other Locations

United States-New Jersey-Skillman

Organization

Johnson & Johnson Consumer Inc. (6101)

Job Function

Quality

Requisition ID

8872200723

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