Associate Director PV NC CAPA

Johnson & Johnson New Planned Consumer Health Company is currently recruiting for an Associate Director PV NC CAPA. This position may be located in Skillman, NJ, Fort Washington, PA, or remote.

Johnson & Johnson New Planned Consumer Health Company, based in Skillman, N.J., is one of the world's largest consumer health and personal care products companies. 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.

Job Description:

As a member of the Quality Organization, the Associate Director will be responsible for providing quality management oversight of the Pharmacovigilance (PV) Non-Conformance/Corrective and Preventative Action management process in the Kenvue organization. The position will be responsible for: Leading an efficient and effective governance program for review of PV NC/CAPA, deliverables, status, & metrics globally across various functions within the Kenvue organization; Reviewing and approving PV NC/CAPA; Establishing methods to accurately track and report Kenvue Pharmacovigilance (PV) NC/CAPAs as required (including to the PSMF); Owning, maintaining and aligning related controlled documents to standards, policies and associated requirements and leading the team to drive process improvements.

Key Responsibilities:

• The Associate Director will have responsibility for ensuring the investigation and CAPA owners are progressing to plan by monitoring status and providing feedback and comments to direct progress during investigation and root cause analysis phases, and during the preparation of Corrective/Preventative action plans and effectiveness monitoring, plans to assure robust solutions are implemented.
• The Associate Director will be responsible as the PV NC/CAPA business process owner for proactively driving process improvements in the PV NC/CAPA process/procedure and is a subject matter expert in PV NC/CAPA management process and system. This position will ensure that the Kenvue PV NC/CAPA system is in an Inspection Ready state. Additionally responsible for contributing to the Pharmacovigilance System Master File for all annexes and PSMF-content required for PV NC/CAPA.

• Provide coaching, support, and leadership to the PV CAPA team, coach and lead teams to execute activities such as identifying owners, facilitating alignment with business partners when required, preparing metrics and analytic documentation, and presenting to review boards.
• The Associate Director will be responsible as the PV NC/CAPA business process owner for proactively driving process improvements in the PV NC/CAPA process/procedure and is a subject matter expert in PV NC/CAPA management process and system. This position will ensure that the Kenvue PV NC/CAPA system is in an Inspection Ready state. Additionally responsible for contributing to the Pharmacovigilance System master file for all annexes and PSMF content required for PV NC/CAPA.
• Leads and chairs functional (Safety) CRB and company-level PV NC/CAPA compliance governance oversight across all PV-related NC/CAPA.
• Facilitate regular CAPA status and metric reports to ensure senior management awareness.
• Participate in governance/oversight activities including trend identification, assessment, or another quality review.
• Identify risks for QSMR or Escalation.

Ensures that functions outside of Medical Safety that own PV NC/CAPA are meeting compliance

Position Requirements:

• A minimum of a bachelor’s Degree in a scientific or business-related discipline with at least 9 years of experience in a regulated (pharmaceutical, medical device, consumer, or equivalent) environment is required
• Expert NC/CAPA knowledge including investigation and root cause analysis is required.
• Good problem-solving skills are required. Experience in Quality Management and/or Process Excellence concepts and practices is strongly required
• The ability to improve processes and generate operational efficiencies in a complex, global environment is required
• A post-baccalaureate degree in management or quality/compliance or related discipline is preferred
• The ability to collaborate, maintain excellent multidisciplinary interactions, and coordination business objectives is required
• The ability to work in a global, matrix environment and collaborate effectively with stakeholders in various other organizations is required

Preferred Competencies:

• Ability to utilize appropriate initiative and autonomy in achieving objectives; works independently
• Requires management skills for multidisciplinary interactions and coordination. Facilitates resolution of complex issues and must manage stakeholders at varying levels of management across multiple organizations. Requires a level of skill in managing difficult situations constructively
• Excellent communication and writing skills demonstrated by the ability to write executive summaries and ad hoc reports promptly and clearly as well as compile and present data to other professionals
• Requires strong analytical skills to examine data and perform analysis as to suitability for the purpose of compliance documentation in support of root cause analysis or effectiveness monitoring
• Requires autonomy in decision-making to approve the appropriateness, effectiveness, quality, and compliance of documented robust investigation, root cause analysis, and corrective/preventative action plans
• Requires critical thinking and ability to identify compliance risks and issues for Escalation properly
• Pharmacovigilance knowledge is preferable

The anticipated base pay range 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 http://jobs.kenvue.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.