Executive Director, Global Distribution Quality

Working Location: MASSACHUSETTS, WESTBOROUGH 

Workplace Flexibility: Hybrid

Are you looking for a company that cares about people’s lives and health, including yours? Let’s inspire healthier lives, together.

 

Olympus, a leading medical technology company, has focused on making people’s lives better for over 100 years.

Our Purpose is to make people’s lives healthier, safer, and more fulfilling.

 

Our Core Values are reflected in all we do: Integrity – Empathy – Agility – Unity – Long-Term View

 

We deliver on our purpose and our core values by staying True to Life.

Job Description

The Executive Director of Quality Process Improvement - Distribution will be responsible for establishing, maintaining, and continuously improving the Quality Management System for both Olympus distribution sites and the requirements of our third-party distributors. This role will focus on developing and implementing efficient, harmonized quality processes compliant with global regulatory requirements. In working with regional (Americas, EMEA, Japan, APAC) Distribution Quality leaders they will ensure execution of customer requirements within the boundaries of the quality processes. This role will also serve as a subject matter expert for the quality process controls needed for the distribution value stream and serve as the Global Process Owner (GPO) for the Product Ship Hold process. The Executive Director of Quality Process Improvement - Distribution will report to the VP of Global Product Distribution Quality, and work collaboratively with other functions such as Supply Chain Management (SCM), Service, Sales, Market Quality, and Regulatory Affairs to achieve organizational objectives.

Job Duties

• Develop and implement a quality management system and processes governing distribution and ensure consistent, compliant, and efficient execution.
• Serve as or manage the team accountable for Distribution quality process ownership across a global scope.
• Foster and maintain a customer-focused quality mindset throughout the organization.
• Oversee the Global Ship Hold process by collaborating with the Regional Quality, Manufacturing, Service & Repair and Corporate Field Corrective Action teams.
• Establish, track and trend metrics to ensure QMS effectiveness. Including governance and execution of the Management Review requirements for distribution.
• Lead programs to improve systems and processes to consistently meet or exceed regulatory & customer requirements.
• Drive data-driven approaches to identify areas of quality risk and customer dissatisfaction, initiate appropriate corrective actions/ preventive actions to ensure effective and timely resolution commensurate with risk.
• Assist Regional Distribution Quality leaders to ensure audit and inspection readiness.
• Provide quality and compliance expertise and guidance to Distribution and Supply Chain colleagues globally.
• Other duties as assigned.

Job Qualifications

Required:

• A BA/BS degree or equivalent in a Life Science, Engineering, or Physical Science.
• A minimum of 12 years of experience in quality management or compliance functions within the MedTech industry. Strong understanding of Distribution requirements across global regions.
• Demonstrated comprehensive expertise in the interpretation and application of FDA regulations and other global regulations & standards governing CGMPs.
• Proven experience in designing, implementing, and improving quality systems and metrics.
• Set / deliver to global quality objectives/KPIs, reviews and assesses ongoing performance of direct reports as well as ‘dotted line’ reports (as may be required).
• Willingness to travel international up to 25-50% of the time and work outside of normal business hours to support global business operations.

 

Preferred:

• Advanced technical degree and MBA preferred.
• Proactive approach to quality and compliance, with a focus on innovation and adaptation in a fast-paced environment.
• Experience with LEAN/Six Sigma is preferred to drive process discipline in this global role.
• Strong ability to think and act globally, be a 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 influence key stakeholders across the business.
• Persistence to continuously improve, never settling for status quo, while keeping customer satisfaction and customer value central.
• Establish, manage, coach and develop a high performing team that meets agreed objectives on time and on budget, while de