Olympus Corporation
Senior Director, Complaint Management and Post-Market Surveillance Transformatio
Olympus Corporation, Center Valley, Pennsylvania, United States
Overview
Senior Director, Complaint Management and Post-Market Surveillance Transformation at Olympus Corporation. This position will establish and lead execution of plans to optimize the global Post Market Surveillance (PMS) function. The 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, positioning the organization as a leader in proactive, data-driven post market surveillance throughout product lifecycles. This role will partner closely with functions within and outside of Quality, including Regulatory Affairs, Information Technology, Service, Repair, Manufacturing, and Commercial teams 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 forums including executive leadership, while working with PMS teams to investigate, analyze and resolve issues impacting patient safety and compliance.
Proactively identify risks and issues that could impact the successful execution of objectives. Escalate 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 experience.
Job Qualifications
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 and 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 global regulations and standards including FDA Quality System Regulations and ISO 13485:2016.
Strength in people management, including coaching and development of individuals to support their current role and future career goals.
Strong attention to detail; ability to operate efficiently, proactively, and effectively in a fast-paced environment.
Strong interpersonal, verbal and written communication skills with the ability to interact with and influence all levels of the organization.
Must be able to work independently, self-motivated, with a sense of ownership and urgency to drive results.
Proven analytic and problem-solving skills.
Travel to other facilities/locations may be required, up to 15%.
Why join Olympus? We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.
Competitive salaries, annual bonus and 401(k) with company match
Comprehensive medical, dental, vision coverage effective on start date
24/7 Employee Assistance Program
Free live and on-demand Wellbeing Programs
Generous Paid Vacation and Sick Time
Paid Parental Leave and Adoption Assistance
12 Paid Holidays
On-Site facilities and programs where applicable
Equal Opportunity Olympus is committed to equal employment opportunity and providing reasonable accommodations in the hiring process for individuals with disabilities. If accommodations are needed, please contact the HR team.
Headquartered in Tokyo, Olympus employs thousands of people worldwide and is dedicated to improving patient outcomes through innovative medical technologies.
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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 forums including executive leadership, while working with PMS teams to investigate, analyze and resolve issues impacting patient safety and compliance.
Proactively identify risks and issues that could impact the successful execution of objectives. Escalate 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 experience.
Job Qualifications
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 and 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 global regulations and standards including FDA Quality System Regulations and ISO 13485:2016.
Strength in people management, including coaching and development of individuals to support their current role and future career goals.
Strong attention to detail; ability to operate efficiently, proactively, and effectively in a fast-paced environment.
Strong interpersonal, verbal and written communication skills with the ability to interact with and influence all levels of the organization.
Must be able to work independently, self-motivated, with a sense of ownership and urgency to drive results.
Proven analytic and problem-solving skills.
Travel to other facilities/locations may be required, up to 15%.
Why join Olympus? We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.
Competitive salaries, annual bonus and 401(k) with company match
Comprehensive medical, dental, vision coverage effective on start date
24/7 Employee Assistance Program
Free live and on-demand Wellbeing Programs
Generous Paid Vacation and Sick Time
Paid Parental Leave and Adoption Assistance
12 Paid Holidays
On-Site facilities and programs where applicable
Equal Opportunity Olympus is committed to equal employment opportunity and providing reasonable accommodations in the hiring process for individuals with disabilities. If accommodations are needed, please contact the HR team.
Headquartered in Tokyo, Olympus employs thousands of people worldwide and is dedicated to improving patient outcomes through innovative medical technologies.
#J-18808-Ljbffr