Senior Manager Field Action & Escalation

We are searching for the best talent for Senior Manager Field Action & Escalation. This is a hybrid role available in multiple cities within the United States and Puerto Rico.

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.

• Drive operational excellence of product escalations and field action processes under applicable J&J procedures and regulatory requirements.
• Manage Med Tech 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 Med Tech organizations.
• Support OUS affiliates, monitoring field action reporting through action closure, identifying process improvements to ensure timely closures.
• Establish and maintain policies and procedures to ensure compliance with local, state and federal environmental regulations and standards including compliance with all Food & Drug Administration (FDA) and European Union Medical Device Directives (MDD)/European Union Medical Device Regulation (MDR) as well as all other applicable global regulatory requirements.
• 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.
• Participate and stay well-informed of enterprise solutions and their impact on emerging field action and product quality escalation internal and external standard changes.
• Establish and maintain 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, ensure that subordinates follow all company guidelines related to health, safety and environmental practices and that all resources needed to do so are available and in good condition, if applicable.
• Responsible for ensuring personal and company compliance with all federal, state, local and company regulations, policies, and procedures.
• Perform other duties assigned as needed.

• BA/BS degree or equivalent is required.
• Eight (8) years of experience in the Pharmaceutical, Medical Device or Biologics industry with managerial experience is required.
• Experience owning & executing Quality system processes strongly preferred.
• Proven experience in successfully collaborating across functions and delivering business results.
• Strong documentation skills and technical writing capability.
• Experience in supporting health authority and/or Notified Body inspections.

• Collaboration
• Compliance Management
• Consulting
• Corrective and Preventive Action (CAPA)
• Data Quality
• Developing Others
• Incident Management
• Inclusive Leadership
• Leadership
• Operations Management
• Performance Measurement
• Quality Control (QC)
• Quality Management Systems…