Manager, Pharmacovigilance(Pv) Capa Management

Janssen Research & Development a member of the Johnson & Johnson Family of Companies is recruiting for a Manager, Pharmacovigilance (PV) CAPA Management! This position can be located anywhere in the United States or Canada. Remote work may be considered on a case-by case basis and if approved by the business.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

The Manager will be responsible for providing quality management oversight of the Pharmacovigilance (PV) CAPA management process as a member of the CAPA and Issue Management team. The Manager will monitor investigations and approvals to ensure that all required information is captured and documented with relation to PV-related CAPAs globally. The Manager 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 preparation of Corrective/Preventative action plans and effectiveness monitoring plans. The Manager will be responsible for proactively driving process improvements in the CAPA management process and is a subject matter expert in CAPA management process and system.
Key Responsibilities:

• PV CAPA reviewer/approver for PV CAPA Management Process.
• Facilitate the process of initiation of investigations and CAPAs, monitor progress and perform reviews/approvals.
• Ensure that CAPA procedures and requirements are followed and met. Uphold standards for quality and compliance in pharmacovigilance.
• Escalate and involve stakeholders for resolution as needed, issues impacting the progress toward completion of investigations, root cause analysis, impact analysis, and closure of CAPA Records.
• Review evidence and approve closure of CAPA plans and effectiveness monitoring plans.
• Facilitate regular CAPA status and metric reports to ensure senior management awareness.
• Participate in external and internal audits and regulatory inspections.
• Perform other duties as necessary in support of the end-to-end CAPA governance, oversight and process

A minimum of a Bachelor's or equivalent University degree is required, with a focus in Nursing or Science preferred.
Experience and Skills:

Required:

• Knowledge and experience with Health Authority Regulations for pharmacovigilance, audits and inspections, and quality and compliance functions within the pharmaceutical industry usually exhibited by 5 years of experience in regulated environment.
• A minimum of 6 years relevant work experience
• Strong CAPA knowledge, strong Analytical and data skills.
• Excellent organization skills with ability to handle multiple, concurrent activities simultaneously.
• Excellent communication and writing skills demonstrated by the ability to develop clear and concise professional correspondence.
• Ability to maintain excellent multidisciplinary interactions and coordination. Ability to work in a global, matrix environment and collaborate effectively with stakeholders in various other organizations.

• Experience in pharmaceutical safety related areas
• Experience in Quality Management and/or Process Excellence concepts and practices
• Project management experience

• This position may require up to 5% domestic & international travel

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.

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.

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.]