Global Director Post Market Surveillance Service Strategy & Programs - Olympus Corporation of the Americas
Center Valley, PA
About the Job
Working Location: NATIONWIDE
Workplace Flexibility: Field
_For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. _ __
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.
Our five Core Values empower us to achieve Our Purpose:
Patient Focus, Integrity, Innovation, Impact and Empathy.
Learn more about Life at Olympus (https://www.olympusamerica.com/careers) .
_Please note: All correspondence will be sent from our Olympus domain (@Olympus.com). If you receive correspondence from an entity other than @Olympus.com, it is likely not legitimate._
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.
Why join Olympus?
_We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture._
Equitable Offerings you can count on:
+ 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 Child Daycare, Café, Fitness Center
Connected Culture you can embrace:
+ Work-life integrated culture that supports an employee centric mindset
+ Offers onsite, hybrid and field work environments
+ Paid volunteering and charitable donation/match programs
+ Diversity Equity & Inclusion Initiatives including Employee Resource Groups
+ Dedicated Training Resources and Learning & Development Programs
+ Paid Educational Assistance
*US Only
Center Valley, PA and Westborough, MA
Are you ready to be a part of our team?
Learn more about our benefit and incentives (https://www.olympusamerica.com/careers/benefits-perks) .
At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.
For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.
Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com .
Olympus is dedicated to building a diverse, inclusive and authentic workplace
We recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect. We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive.
Let’s realize your potential, together.
It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.
Applicants with Disabilities:**
As a Federal Contractor, Olympus is committed to ensuring our hiring process is accessible to everyone. If you need an accommodation in order to complete the application or hiring process, please contact Olympus via email at OCAAccommodations@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).
Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs (QA/RA)
Workplace Flexibility: Field
_For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. _ __
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.
Our five Core Values empower us to achieve Our Purpose:
Patient Focus, Integrity, Innovation, Impact and Empathy.
Learn more about Life at Olympus (https://www.olympusamerica.com/careers) .
_Please note: All correspondence will be sent from our Olympus domain (@Olympus.com). If you receive correspondence from an entity other than @Olympus.com, it is likely not legitimate._
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.
Why join Olympus?
_We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture._
Equitable Offerings you can count on:
+ 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 Child Daycare, Café, Fitness Center
Connected Culture you can embrace:
+ Work-life integrated culture that supports an employee centric mindset
+ Offers onsite, hybrid and field work environments
+ Paid volunteering and charitable donation/match programs
+ Diversity Equity & Inclusion Initiatives including Employee Resource Groups
+ Dedicated Training Resources and Learning & Development Programs
+ Paid Educational Assistance
*US Only
Center Valley, PA and Westborough, MA
Are you ready to be a part of our team?
Learn more about our benefit and incentives (https://www.olympusamerica.com/careers/benefits-perks) .
At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.
For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.
Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com .
Olympus is dedicated to building a diverse, inclusive and authentic workplace
We recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect. We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive.
Let’s realize your potential, together.
It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.
Applicants with Disabilities:**
As a Federal Contractor, Olympus is committed to ensuring our hiring process is accessible to everyone. If you need an accommodation in order to complete the application or hiring process, please contact Olympus via email at OCAAccommodations@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).
Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs (QA/RA)
Source : Olympus Corporation of the Americas
