Senior Program Manager, Distribution Quality - 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 Senior QMS Program Manager for Distribution Quality is responsible to design and create global standards across the Olympus Distribution network in compliance with Olympus Corporate Quality Systems and industry regulations. The role will also develop the Distribution QMS strategy including the management arrangements for key milestones and demonstrating solid progress against plan. The role will develop collaborative relationships with functional leaders to identify and champion continuous improvement efforts, support employee training on QMS and establish effective comprehensive data collection for analytics and reporting.
Job Duties
+ Proactively lead quality QMS support of Distribution activities globally for Olympus sites, 3PL’s, and Distributors. Ensure right first-time quality QMS implementation and compliance with all applicable laws and regulations.
+ Implement, maintain, and continuously improve quality management systems that align with globally harmonized processes and ensure consistent, compliant and efficient execution.
+ Anticipate and identify quality and compliance risks and proactively drive actions to mitigate. Ensure a sense of urgency commensurate with risk.
+ Serves as the subject matter expert for quality QMS activities, advising leadership and cross-functional departments on complex topics and ensuring compliant execution of work.
+ Identify compliance gaps and drive timely and effective actions to mitigate.
+ Ensure timely and thorough investigation and resolution of quality opportunities (nonconformance reports, customer complaints) and effective actions to correct and mitigate recurrence (CAPA) with respect to internal sites, 3PL’s, and Distributors. Support internal sites, 3PL’s and Distributors with complex investigations to identify causes of problems to safeguard patient safety and business continuity.
+ Ensure audit and inspection readiness and successful outcomes. Ensure any observations are adequately addressed and completed on time.
+ Engage in a positive manner with team members from all disciplines to ensure common goals are being met, lead initiatives to enhance the culture of quality and maintain a patient and customer focused quality mindset.
+ Establish strategic plans and drive tactical execution for new and changing QMS requirements while maintaining alignment with global strategies and supporting business growth.
+ Conduct periodic on-site audits of distribution service partners to verify compliance with quality standards and agreements.
+ Facilitate regular communication and feedback loops between the company and its internal sites, 3PL’s, and distributors to promote transparency and continuous improvement.
+ Monitor industry trends and best practices to continually refine and enhance the distributor quality management framework.
+ Contribute to training and development programs for internal sites, 3PL’s, and distributors to ensure they stay updated on product knowledge, regulatory changes, and QA/RA perspectives.
+ Work with regional and business unit teams to address and resolve any QMS issues related to internal sites, 3PL’s, and distributor’s performance or compliance.
+ Other duties as assigned.
Job Requirements
Required:
+ Bachelor’s degree in Quality Management, Supply Chain Management, Engineering, or Physical Science.
+ Minimum of 10 years of quality management experience in the medical device industry or 8 years in a regulated industry.
+ Experience with durable medical devices, and a strong understanding of distribution requirements to ensure they continue to meet safety and performance specifications over their usable life.
+ Proven experience in developing and managing quality agreements with service partners and internal stakeholders.
+ Strong understanding of regulatory requirements and compliance standards in the medical device industry.
+ Understanding of supply chain principles with a focus on international quality requirements for distribution of products (e.g. ISO 13485, EUMDR, FDA CFR 820 etc.)
+ Demonstrated comprehensive expertise in the interpretation and application international regulations, guidance and standards governing Good Distribution Practices
+ Will work with global teams, availability will include working across global time zones. International and domestic travel up to 15% of the time.
Preferred:
+ Experience operating in a matrix environment is strongly preferred.
+ Proactive approach to quality and compliance, with a QMS focus on innovation and adaptation in a fast-paced environment.
+ Effective Verbal and Written Communicator
+ Strong ability to think and act globally, be fearless change agent while managing risks, develop future visions and engage broad audiences to drive transformation.
+ Capable of presenting clear and insightful thoughts based in facts and data gain trust, build confidence and to influence key stakeholders across the business.
+ Persistence to continuously improve, never settling for status quo, while keeping customer satisfaction and customer value central.
+ Driving cultural change in a complex and diverse Olympus organization.
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) .
The anticipated base pay range for this full-time position working at this location is $114,213.00 - $159,898.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). Olympus considers a variety of factors when determining actual compensation for this position including: level of experience, working location, and relevant education and certifications.
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 Senior QMS Program Manager for Distribution Quality is responsible to design and create global standards across the Olympus Distribution network in compliance with Olympus Corporate Quality Systems and industry regulations. The role will also develop the Distribution QMS strategy including the management arrangements for key milestones and demonstrating solid progress against plan. The role will develop collaborative relationships with functional leaders to identify and champion continuous improvement efforts, support employee training on QMS and establish effective comprehensive data collection for analytics and reporting.
Job Duties
+ Proactively lead quality QMS support of Distribution activities globally for Olympus sites, 3PL’s, and Distributors. Ensure right first-time quality QMS implementation and compliance with all applicable laws and regulations.
+ Implement, maintain, and continuously improve quality management systems that align with globally harmonized processes and ensure consistent, compliant and efficient execution.
+ Anticipate and identify quality and compliance risks and proactively drive actions to mitigate. Ensure a sense of urgency commensurate with risk.
+ Serves as the subject matter expert for quality QMS activities, advising leadership and cross-functional departments on complex topics and ensuring compliant execution of work.
+ Identify compliance gaps and drive timely and effective actions to mitigate.
+ Ensure timely and thorough investigation and resolution of quality opportunities (nonconformance reports, customer complaints) and effective actions to correct and mitigate recurrence (CAPA) with respect to internal sites, 3PL’s, and Distributors. Support internal sites, 3PL’s and Distributors with complex investigations to identify causes of problems to safeguard patient safety and business continuity.
+ Ensure audit and inspection readiness and successful outcomes. Ensure any observations are adequately addressed and completed on time.
+ Engage in a positive manner with team members from all disciplines to ensure common goals are being met, lead initiatives to enhance the culture of quality and maintain a patient and customer focused quality mindset.
+ Establish strategic plans and drive tactical execution for new and changing QMS requirements while maintaining alignment with global strategies and supporting business growth.
+ Conduct periodic on-site audits of distribution service partners to verify compliance with quality standards and agreements.
+ Facilitate regular communication and feedback loops between the company and its internal sites, 3PL’s, and distributors to promote transparency and continuous improvement.
+ Monitor industry trends and best practices to continually refine and enhance the distributor quality management framework.
+ Contribute to training and development programs for internal sites, 3PL’s, and distributors to ensure they stay updated on product knowledge, regulatory changes, and QA/RA perspectives.
+ Work with regional and business unit teams to address and resolve any QMS issues related to internal sites, 3PL’s, and distributor’s performance or compliance.
+ Other duties as assigned.
Job Requirements
Required:
+ Bachelor’s degree in Quality Management, Supply Chain Management, Engineering, or Physical Science.
+ Minimum of 10 years of quality management experience in the medical device industry or 8 years in a regulated industry.
+ Experience with durable medical devices, and a strong understanding of distribution requirements to ensure they continue to meet safety and performance specifications over their usable life.
+ Proven experience in developing and managing quality agreements with service partners and internal stakeholders.
+ Strong understanding of regulatory requirements and compliance standards in the medical device industry.
+ Understanding of supply chain principles with a focus on international quality requirements for distribution of products (e.g. ISO 13485, EUMDR, FDA CFR 820 etc.)
+ Demonstrated comprehensive expertise in the interpretation and application international regulations, guidance and standards governing Good Distribution Practices
+ Will work with global teams, availability will include working across global time zones. International and domestic travel up to 15% of the time.
Preferred:
+ Experience operating in a matrix environment is strongly preferred.
+ Proactive approach to quality and compliance, with a QMS focus on innovation and adaptation in a fast-paced environment.
+ Effective Verbal and Written Communicator
+ Strong ability to think and act globally, be fearless change agent while managing risks, develop future visions and engage broad audiences to drive transformation.
+ Capable of presenting clear and insightful thoughts based in facts and data gain trust, build confidence and to influence key stakeholders across the business.
+ Persistence to continuously improve, never settling for status quo, while keeping customer satisfaction and customer value central.
+ Driving cultural change in a complex and diverse Olympus organization.
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) .
The anticipated base pay range for this full-time position working at this location is $114,213.00 - $159,898.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). Olympus considers a variety of factors when determining actual compensation for this position including: level of experience, working location, and relevant education and certifications.
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