Senior Director, Global Product Monitoring Triage & Vigilance (Hybrid)

* Serves as a strong mentor, coach, people manager, leader, and subject matter expert in post-market surveillance (particularly, in complaint handling and vigilance reporting) providing both strategic and tactical direction to support growth, maintain compliance, and drive toward post-market excellence.* Directs a global, high-performance team of over 50 people focused on complaint handling and vigilance while driving a culture of excellence and strategic post-market programs and processes for the organization.* Leads people managers and individual contributors, ensuring they are effective, efficient, assisted, and supported to succeed in their roles and their continual professional development. Ensures their selection, orientation, development, and retention to carry out their responsibilities. Conducts performance appraisals and ensures development opportunities for staff.* Maintains training and job requirements for personnel, including job descriptions/profiles, and ensures their training is completed by established due dates.* Develops and maintains product knowledge of existing and new products and ensures team members do the same.* Engages globally with internal and external stakeholders, developing and maintaining strong relationships to ensure effective processes while identifying improvements to drive efficiency and compliance.* Represents GPM at cross-functional, multi-level, and external meetings.* Drives operational excellence by helping to ensure that post-market surveillance processes and practices reflect industry best practices. Develops and maintains a culture of continuous process improvement.* Adheres to all regulatory compliance and quality standards, including company policies and procedures and U.S. FDA, Health Canada, EU MDR, and other applicable quality system and country-specific regulations, and establishes, maintains and promotes a culture of quality with a keen focus on patient safety and customer experience.* Maintains awareness of new or revised regulations, standards, and/or guidelines, particularly as they pertain to post-market vigilance and surveillance. Reviews changes in international laws and regulations and assesses their impact and makes recommendations to ensure compliance.* Interfaces with notified bodies and regulatory authorities as necessary, particularly in the context of vigilance reporting, RFAIs, field actions, and audits.* Reviews, evaluates and approves document changes, especially those concerning significant changes and revisions.* Provides front-room and/or back-room leadership and support during inspections by regulatory authorities (such as competent authorities and notified bodies).* Ensures follow-up on activities related to internal and external QMS audits, managing and resolving any nonconformances or other findings.* Ensures required documentation, records, and reports are complete, accurate, and properly maintained.* Monitors, identifies, manages, and escalates critical events, quality/safety signals, and trends and works with cross-functional partners to drive response and improvement based on post market feedback. Implements prompt actions as necessary to ensure product safety and effectiveness.* Ensures all appropriate levels of leadership are informed of any significant concerns, action plans, and status, driving organizational awareness of key post market issues and signals.* Identifies process improvement opportunities and, where needed, leads corrective and preventive actions (CAPAs) and other process improvements. Works closely with internal and external stakeholders to drive the initiation of process NCs, CAPAs and supplier corrective actions (SCARs) when appropriate. Provides support or leadership to global expansion efforts.* Ensures key performance indicators are met or exceeded and works to ensure detection of potential issues (such as, bottlenecks and backlogs) before they arise and rapidly solving issues when they do arise.* Performs other duties as required.* Reports to the Vice President, Global Post Market Surveillance & Compliance.* Oversee global complaint intake, determination, and evaluation and global post-market vigilance activities.* Comply with established global regulations and procedures for complaint and reportable event handling (post-market vigilance) to ensure timely, uniform, and accurate complaint processing and issuance of initial, supplemental, and final reports to regulatory agencies for reportable events.* Oversee global post-market professionals responsible for the timely and effective handling, management, preparation, and assembly of information for complaint determination, complaint evaluation, and vigilance reporting.* Maintain and/or utilize reports and dashboards to identify delinquency or backlog in all aspects of the complaint handling and vigilance reporting process and to manage a large workforce in a high-throughput environment.* Drive collaboration with Product Support, Customer Care, and other functional areas to enable and continuously improve customer experience and support improvements throughout the service lifecycle.* Where appropriate, ensure escalation and cross-functional engagement with stakeholders around the world to enable rapid response to emerging issues and opportunities.* Provides independent assurance that sound post market surveillance sub-processes are maintained and continuously improved to support outstanding customer experience and growth of the business.* Consistently exercises independent judgment and discretion in matters of significant impact to the organization.* Establishes, maintains and promotes a strategy for compliance with quality objectives and requirements.* Proactively leads and communicates with internal groups to gather necessary inputs and facts to execute clear decisions and actions, including driving prioritization of product intelligence insights gained through post market feedback.* Collaborates with internal groups to provide relevant and critical clinical and technical information to help identify product improvement opportunities.* Identifies risk exposures that may impact the achievement of company objectives.* Makes sound decisions with reasonable foresight as to potential risks, alternatives, and benefits.* Assists in risk assessments as needed in collaboration with Medical Affairs, R&D, and other internal experts.* Provides input to conclusions to be included in complaint files, regulatory reports, RFAIs, and/or other regulatory authority-facing records.* Self-reflective and aware of his/her own limitations; leads by example and drives the organization's performance with an attitude of continuous improvement by being open to feedback and self-improvement.* Builds competitive advantage by assembling a high-performing team.* Inspires trust and followership in others through compelling influence, passion in his/her beliefs, and active drive.* Creates a sense of purpose/meaning for the team that generates followership beyond his/her own personality and engages others toward the greater purpose of the entire organization.* Encourages others to share the spotlight and visibly celebrates and supports the success of the team.* Builds strong relationships, demonstrating high emotional intelligence and ability to communicate clearly and persuasively* Attracts and recruits top talent, motivates the team, delegates effectively, celebrates diversity within the team, and manages performance; widely viewed as a strong developer of others.* Sets clear goals and expectations, tracks progress against the goals, ensures timely feedback, and addresses performance problems and issues promptly.* Delegates responsibility and works with others to coach and develop their capabilities.* Flexibility in style to bring out the best in people with different backgrounds and working styles, while unifying them in purpose, role clarity, and expectations related to deliverables.*
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