Senior Director, Post Market Surveillance Transformation

Working Location: NATIONWIDE 

Workplace Flexibility: Field

 

For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. ​​

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Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.

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Our five Core Values empower us to achieve Our Purpose: 

 

Patient Focus, Integrity, Innovation, Impact and Empathy. 

 

Learn more about Life at Olympus.

 

 

Job Description

This position will establish and lead execution of plans to optimize our global Post Market Surveillance function.  This senior leader will drive cross-functional initiatives to enhance product safety, regulatory compliance, and customer experience through advanced data analytics, digital tools, and streamlined processes.  This individual to position the organization as a leader in proactive, data-driven post market surveillance processes to ensure products remain safe and effective throughout their lifecycle.  This role will partner close with other functions both within and outside of Quality, including Regulatory Affairs, Information Technology, Service, Repair, Manufacturing, Commercial teams and business leaders across all global regions. 

Job Duties

• Partner with the Global VP of Post Market Surveillance to establish strategic plans to optimize the PMS function and ensure efficient and effective processes using advanced data analytics to drive digitalization and process simplification while ensuring sustained compliance.
• Identify priorities and ensure robust solutions to challenges that are effectively implemented in a timely manner.
• Define new strategies to optimize operations and execution. 
• Lead cross-functional efforts to redesign workflows that minimize administrative burden and enable teams to focus on value-added activities. 
• Serve as a trusted member of the PMS leadership team, representing the function in various forums including those with executive leadership, while working with the PMS teams to help investigate, analyze and resolve issues impacting patient safety and compliance. 
• Proactively identify risks and issues that could impact the successful execution of objectives.  Escalates risks and issues and present solutions to resolve and mitigate risk.   
• In partnership with IT and PMS leaders, drive the digital transformation of PMS processes by implementing advanced tools and platforms, including AI and automation to integrate digital ecosystems that support real-time surveillance and reporting. 
• Stay abreast of emerging digital technologies and regulatory trends to ensure sustained compliance.
• Lead continuous improvement initiatives to eliminate inefficiencies in global PMS processes to improve responsiveness, compliance, and user/customer (internal and external) experience.  

Job Qualifications

Required:

• Bachelor’s degree required; Master’s preferred.
• Minimum of 12 years experience directly managing quality teams in the life sciences industry with related work experience in product customer complaint and post market surveillance processes.
• Strong experience in lean six sigma. 
• Demonstrated experience driving transformation at a global level with cross-functional teams, hands on leadership/accountability of driving programs and projects to completion with aggressive timelines.
• Experience in advanced data analysis and digital transformation.
• Experience in developing and delivering executive-level presentations.
• Experience working in or with global organizations across multiple global sites (Americas, EMEA, Japan, APAC) and functions.
• Excellent understanding and working knowledge of appropriate global regulations and standards including FDA Quality System Regulations and ISO 13485