Senior Manager, Quality - Japan

This position will act as the Quality Leader for Illumina Japan and partner cross-functionally to lead the Illumina Japan Quality Team, manage quality activities for Japan to ensure quality compliance to applicable regulations and standards, as well as to the Illumina Quality Management System.    

This position is responsible for implementation of Illumina Japan Quality activities, QMS and projects to monitor, measure and improve Illumina’s quality performance and compliance as well as Illumina product quality requirements.  This includes responsibility under the Japan QMS Ordinance 169 to ensure total life cycle management for IVD products to meet Japanese regulation requirements as the MAH General Controller (Soukatsu) at lllumina Japan.

Responsibilities:

• Ensure the quality activities meet customer, corporate, and / or internal requirements and any other related requirement within the Quality Management System.
• Support the Illumina Japan activities with focus on compliance with Illumina QMS and applicable requirements and including responsibility for total life cycle management of IVD product to meet Japanese regulation as MAH General Controller (Soukatsu)
• Partner effectively cross functionally within the Illumina Japan team and provide advice on Quality matters to senior management for clinical business success as MAH General Controller (Soukatsu)
• Leads organizational management of a small team of Quality Specialists for Quality activities at Illumina Japan.
• Builds effective teams that accomplish sustaining, supporting and project objectives on a prescribed schedule and where applicable within a prescribed budget.
• Makes recommendations on resource needs and facilitates procurement of resources, resolution of resource conflicts, and business justifications and/or trade-offs related to resource utilization.
• Grows talent within the organization by leading employee development initiatives.
• Monitor and analyze key metrics and drive improvements to QMS processes.
• Develop, review and approve quality system documents to ensure compliance with applicable regulations.
• Participates in the definition of area goals and drives teams to deliver on goals
• Drives continuous improvement initiatives to advance quality processes and capabilities.
• Advocates operationally effective solutions to complex problems.
• Contributes quality and compliance expertise and guidance to teams responsible for addressing specific quality issues.
• Establishes and monitors process metrics and develop action plans as needed
• Works with business process owners to identify and implement solutions to track and action quality KPIs.
• Manage and/or coordinates internal and external compliance audits/ inspections as well as participate in management of corrective action program (i.e., audits, inspections) to ensure timely follow-up, completion and documentation of corrective actions.
• Provides management with plans and status updates on assigned responsibilities and goals and escalates issues in a timely fashion.
• Leads and provides subject matter expertise during internal and external quality system audits for Japan.
• Leads and represents functional area in Japan Management Review and Quality Review processes.
• Provides input to core QMS processes, such as non-conformance, CAPA, and Internal Audits.
• Other such duties that may be determined by Management.

Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.

Requirements:

• 10 years+ of relevant experience.
• Minimum 5 years of experience managing personnel.
• Quality Management System implementation and management experience.
• Must have proven experience in Quality within the medical device, IVD, Biotech or Pharma industry.
• Experience collaborating with cross-functional leadership and operational teams.
• Experience working in a matrixed environment.
• Strong communication and negotiation skills.
• Demonstrated capability in successfully managing and leading change
• Experience with Quality and Project Management methodologies and tools.
• Practice identifying, mitigating, and resolving risks.
• Ability to work effectively in a fast-paced, dynamic environment with shifting and competing priorities.
• Ability to travel domestically and internationally as needed. Estimate 10% of the time.
• Holder of Pharmacist License (Japan) preferred.
• Based in Tokyo, Japan
• Japanese language skills (native level) and English language skills (business level)

All listed requirements are deemed essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.

Experience / Education:

• Bachelor’s degree or equivalent in Biomedical Engineering, Biological/Life Sciences.
• 10+ years of experience.
• Significant experience working in a regulated environment, in-vitro diagnostics or medical devices required.