Senior Director, Post Market Surveillance Transformation

Req ID: 9682

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.

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 13485:2016
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 skills and 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, a sense of ownership with a strong sense of urgency to drive for 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.

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
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.

The anticipated base pay range for this full-time position working at this location is $141,361.00 - $212,041.00 / 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.

You Belong at Olympus

We value a workforce that reflects a wide range of perspectives, backgrounds, and experiences. We foster an environment where all employees feel valued, respected, and supported. And we provide employees with equal access to opportunities for growth and development.

Applicants Requesting Accommodations: Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact 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).

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.

Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs (QA/RA)

Job Segment: Lean Six Sigma, Six Sigma, Quality Assurance, QA, Manager, Management, Quality, Technology

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