Senior Program Manager, Distribution Quality

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.