Global Director Post Market Surveillance Service Strategy & Programs

Job Description

The Global Director of Post Market Surveillance Service Strategy & Programs is responsible for leading the optimization of the Global Post Market Surveillance Service BPO team. This involves enhancing systems, standardizing processes, and implementing quality audits across all regions, driven by data analytics and strategic initiatives. The Director will build and lead a high-performing team to ensure global operations meet or exceed standards, aligning with regulatory requirements and business goals.

They will oversee call center launches, program implementations, and change management initiatives, contributing significantly to the strategic direction and standardization of program management across Olympus. Additionally, the Director will play a key role in fostering strong relationships with internal and external stakeholders. This position reports to the Executive Director of Post Market Surveillance Services.

Job Duties

• Service Consistency and Compliance: Collaborate with Olympus global leadership teams to ensure the service delivered meets expectations for quality, compliance, and international regulations. This includes adherence to FDA standards such as 21 CFR 820.198 (Complaint Handling) and 21 CFR 803.3 (MDR Reporting), aligning with company goals.
• Leadership and Team Development: Build strong program management capabilities within global sites through influential leadership, mentoring, and professional development. Cultivate a team capable of delivering high-performance results in line with organizational objectives. Communicate a compelling vision for program management, driving team engagement and fostering a results-driven culture.
• Continuous Improvement and Stakeholder Engagement: Inspire enthusiasm for continuous improvement in program management across all Olympus regions, leading efforts to enhance efficiency, quality, and compliance in processes. Secure stakeholder buy-in for process improvements, demonstrating clear ROI for proposed enhancements.
• Program and Project Management: Develop and oversee project timelines, budgets, risk mitigation strategies, and communication plans. Ensure alignment with regulatory requirements and corporate priorities. Provide project management support to key functional areas within Post Market Surveillance (PMS), fostering collaboration with external partners and stakeholders.
• Lead cross-functional project teams, establishing goals, strategic direction, and operational plans for assigned programs.
• Risk Management and Compliance: Validate current and future project states to meet or exceed requirements for PMS and other global regulatory authorities. Identify, assess, and mitigate risks related to product safety and performance, ensuring timely corrective actions are initiated as needed.
• Technology and Innovation: Explore and introduce emerging technologies, such as AI and data analytics, to enhance PMS capabilities and streamline surveillance processes. Maintain and optimize technology platforms (e.g., PMS databases, complaint handling systems) to ensure data accuracy, efficiency, and regulatory compliance.
• Workforce Management: Optimize the Global Post Market Surveillance Service Business Process Outsourcing (BPO) team through streamlined systems, standardized processes, and global quality audits. Collaborate with vendors to improve resource allocation, ensuring the right skillsets are deployed effectively to meet SLAs and performance targets. Leverage automation and process improvements to optimize human resource efficiency. Develop and implement scalable workforce strategies for 3rd party vendors, ensuring smooth ramp-up during peak demand (e.g., product launches) and efficient ramp-down during low demand periods. Establish clear guidelines for managing these transitions to minimize service disruption.
• Data-Driven Workforce Optimization: Use data-driven insights to forecast resource needs, balancing operational efficiency, cost-effectiveness, and service quality. Ensure the vendor workforce is optimized through careful monitoring of performance metrics and real-time adjustments as necessary.
• Problem-Solving and Conflict Resolution: Drive creative problem-solving and conflict resolution in daily operations, ensuring issues are resolved swiftly while maintaining operational and regulatory standards.

Job Qualifications

Required:

• BA/BS in Business, communications, or scientific discipline required. Equivalent years of experience in the business operation field and or medical device
• Minimum of 10 years of senior level progressive leadership of a professional staff, or equivalent experience leading teams or work groups required
• Proficient understanding of medical device customer relationship management, including domestic and international medical device regulations which include complaint handling, and regulatory inspections.
• Excellent management communication and people skills required to influence and manage multiple resources, most of which are not under direct authority.
• Skilled in conflict resolution and negotiation.
• Strong communication skills, expresses ideas fluently and logically, is open to input and can be depended on for truthfulness.
• Creates an atmosphere of openness and trust, collaborates, offers support and encouragement. Passionate about customer service excellence.
• Driven by a high degree of integrity, with cultural and core value alignment to Olympus.
• Must have excellent judgment, technical, analytical, and problem-solving skills with the ability to identify complex problems and see them through to resolution.
• Excellent leadership and interpersonal skills with the proven ability to work collaboratively with others.
• Occasional international travel may be required.