Job Information
Olympus Corporation of the Americas Senior Program Manager, Distribution Quality in Center Valley, Pennsylvania
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 Sr. Manager, Business Development Quality Assurance will support Quality Assurance M&A activities throughout the project lifecycle. This role will participate in due diligence of targets and identification of potential compliance risks which could impact the business. The Sr. Manager will identify resourcing and budgeting needs to effectively mitigate the identified risks. This role also participates in transition service planning, integration planning, and integration execution post-close to ensure a smooth transition and integration into Olympus Quality System occurs. This role will be responsible for development of Integration Quality Plans, training, and execution to those plans which requires close collaboration with the Quality Assurance subfunctions.
Job Duties
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.
Work with regional and business unit teams to address and resolve any supplier issues related to internal sites, 3PL’s, and distributor’s performance or compliance.
Oversee the onboarding process, ensuring new internal sites, 3PL’s, and distributors are fully trained and equipped to represent the company's products effectively.
Development and maintenance of Quality Agreements with internal sites, 3PL’s, and Distributors.
Support and collaborate with Supply Chain and Corporate Supplier Quality during the selection and on-boarding of 3PL’s and Distributors.
Establish and maintain global standards for internal sites, 3PL’s and Distributor performance, including quality metrics, compliance requirements, and customer service expectations.
Lead initiatives to improve distributor performance and satisfaction, leveraging data and feedback to drive informed decision-making.
Proactively lead quality supplier support of Distribution activities globally for Olympus distribution sites, 3PL’s, and Distributors. Ensure right first-time quality supplier implementation and compliance with all applicable laws and regulations.
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.
Other duties as assigned.
Job Qualifications
Required:
Bachelor’s degree in Quality Management, Supply Chain Management, Engineering, or Physical Science.
Minimum of 10 years of experience in service provider quality management in the medical device industry or 8 years within a regulated industry.
Experience with durable medical devices, and a strong understanding of supplier distribution requirements to ensure they continue to meet safety and performance specifications over their usable life.
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
Proven experience in designing, implementing, and improving supplier quality systems and metrics.
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 supplier 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)