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 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, with monitoring field action reporting through action closure, identifying process improvements to ensure timeliness 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.
• 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 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