Senior Program Manager, Distribution Quality

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.