Senior Manager Field Action & Escalation

Responsibilities

• Drive operational excellence of product escalations and field action processes under applicable J&J procedures and regulatory requirements.
• Manage MedTech Surgery team responsible for scheduling, coordination and preparation of Product Issue Escalation and Quality Review Board (QRB) Meetings.
• Oversight of the department's budget, hiring, retaining and developing qualified personnel, as well as resolving all personnel issues and employee performance management.
• Provide support to internal and external audit processes. Serve as SME in responsible areas for internal and external audits.
• Monitor key process metrics for product issue escalation and field actions, communicate status and identify opportunities for process improvements across MedTech organizations.
• Support OUS affiliates, with monitoring field action reporting through action closure, identifying process improvements to ensure timeliness closures.
• Act as a representative for J&J Medical Devices to US FDA, worldwide health authorities and notified bodies, as applicable.
• Communicate business-related issues or opportunities to next management level.
• Manage field corrective actions, any associated regulatory actions and follow-ups; lead in product problem resolution as part of follow-up from QRB and CAPA.
• Oversee technology platform supporting the product issue escalation, quality review board, and field action processes to ensure compliance to regulations and standards and effective internal process flow.
• Participates and stays well-informed of enterprise solutions and their impact to emerging field action and product quality escalation internal and external standard changes.
• Establishes and maintains training programs to execute field actions with required stakeholders to effectively determine product quality issue resolution.
• Responsible for communicating business related issues or opportunities to next management level.
• For those who supervise or manage staff, responsible for ensuring that subordinates follow all company guidelines rel

Benefits

Additional Information

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 jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Quality Job Sub Function: Quality Systems Job Category: People Leader All Job Posting Locations: Cincinnati, Ohio, United States of America, Cornelia, Georgia, United States of America, Raritan, New Jersey, United States of America, San Angelo, Texas, United States of America, San Lorenzo, Puerto Rico, United States of America Job Description: About MedTech Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech We are searching for the best talent for Senior Manager Field Action & Escalation. This is a hybrid role available in multiple cities within United States and Puerto Rico. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from various locations to apply and encourage you to review the following states and cities where this opportunity is available: Cincinnati, OH Cornelia, GA San Angelo, TX Raritan, NJ San Lorenzo, PR Purpose: The Senior Manager Field Action & Escalation will have responsibility for the end-to-end process related to product quality issue escalations through the decision-making framework of risk management, quality review boards and field action execution while incorporating worldwide standards and regulations. Additionally, the position will have responsibilities for identifying improvement trends to present opportunities to top management and be responsible for direct report supervision, performance and development planning for the team.

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