embecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. For more information, visitembecta.comor follow our social channels onLinkedIn,Facebook,InstagramandX.
Why join us?
A career at embecta means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our employees can fulfill their life’s purpose through the work that they do every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program – which includes competitive pay, benefits, continuous learning, recognition, career growth and life balance components – is designed to support the varying needs of our diverse and global employees.
Japan Primary Responsibilities
• Provide overall leadership and management of the Japan Quality Management System (QMS) that oversees the complete product lifecycle from design concept through product obsolescence executed by embecta Asia for Japan.
• Serve as MAH General Controller for embecta Japan MAH license, ensuring full compliance with applicable Japan regulations and internal embecta requirements.
• Ensure the Japan QMS encompasses and effectively governs Quality Control, Regulatory Compliance, Complaint Management, Quality Assurance Systems, and Quality Engineering activities.
• Own and maintain Japan-specific quality procedures, work instructions and records aligned with global embecta policies while meeting local regulatory and customer expectations.
• Lead transition and integration activities related to any changes in product portfolio, MAH responsibilities, or distribution models within Japan, ensuring business continuity and compliance.
QMS & Regulatory Compliance
• Ensure that the Japan QMS complies with relevant standards and regulations (e.g., ISO 13485, ISO 14971, Japan MHLW/PMDA requirements, and embecta global procedures).
• Plan, prepare for, and support internal, corporate, notified body, and regulatory inspections and audits; ensure timely closure of audit findings and commitments.
• Partner with Regulatory Affairs to maintain MAH compliance, including vigilance reporting, field safety corrective actions (FSCA), and product registration/notification changes impacting quality responsibilities.
• Monitor and interpret changes in Japan regulatory and standards landscape, translating them into QMS updates and implementation plans.
Complaint Management & Post-Market Surveillance
• Oversee complaint intake, triage, evaluation, and closure processes for Japan, ensuring accuracy, completeness, and timely reporting.
• Ensure robust post-market surveillance and trend analysis for products in Japan, escalating emerging risks and coordinating investigations with global Quality Engineering and manufacturing sites.
• Collaborate with Commercial and Customer Service teams to strengthen complaint reporting culture, training, and controls, while maintaining clear ownership boundaries between functions.
• Lead or support risk assessments, health hazard evaluations, and recall/FSCA-related activities impacting the Japan market.
Continuous Improvement & Kaizen
• Work with the Management team to support organizational change readiness to adopt process initiatives and reinforce the need for change so efforts are sustained long-term.
• Lead and facilitate Kaizen and other continuous improvement activities within the Japan Quality team to remove waste, reduce redundancy, and improve focus on high-value tasks.
• Identify quality improvement opportunities across Japan operations, evaluate root causes, and implement corrective and preventive actions (CAPA) with measurable outcomes.
• Leverage data and quality metrics to prioritize improvement projects and to communicate performance and progress to local and regional leadership.
Cross-Functional Collaboration & Stakeholder Management
• Maintain an influential and effective network and communication with country leadership team members for identifying quality improvement opportunities.
• Collaborate closely with Japan Commercial, Supply Chain/Logistics, Regulatory Affairs, Medical Affairs, and Regional/Global Quality to align quality strategies and initiatives.
• Provide quality input to business decisions impacting Japan, including new product introduction, labeling/IFU changes, and distribution or service model changes.
• Represent Quality in Japan leadership forums, ensuring that patient safety, product quality, and compliance are visibly prioritized.
People Leadership & Development
• Provide leadership directions and clear objectives to Japan Quality associates; coach, mentor, and develop the team to build strong technical and leadership capabilities.
• Ensure appropriate role clarity and succession planning within the Japan Quality team, including Safety Controller, General Controller, and Quality Controller responsibilities.
• Foster a culture of accountability, collaboration, and continuous learning, aligned with embecta’s values and quality mindset.
• Plan and deliver training programs for internal stakeholders on quality system requirements, complaint reporting, and MAH-related responsibilities.
embecta is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
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