Director Quality System and Regulatory Compliance

The Director Quality System and Regulatory Compliance is responsible to support CQOwith the implementation of strategies to develop, implement, and maintain thequality management system (QMS) across HOYA Vision Care entities (HVC), andimprove the level of quality and regulatory compliance in HVC.

This position also owns the global inspection readiness program, oversees the globalISO13485 certification, and creates an effective oversight of HVC entities QMSperformance (e.g.CAPA).

This position owns Global Management review and prepares it in cooperation with site/regional Quality teams.

The Director Quality System and Regulatory Compliance, oversees market’s intelligence and provides proactive gap assessment on competitors field actions and recalls, audits/483 observations, warning letters and other market actions; ensure proactive correction of identified gaps in HVC entities.

The Director Quality System and Regulatory Compliance will be a certified independent auditor (with registration in IRCA) and will be supporting Hoya Corporation audits program of other Hoya divisions.

Duties and Responsibilities

• Develop, implement, and maintain the QMS across HVC entities
• Oversee and ensure compliance of all quality systems elements such as but not limited to documentation, trainings, CAPAs, management review, internal audits, change controls etc to regulatory requirements and quality standards
• Define QMS architecture for implementation across HVCsites
• Define requirements to QMS documents across HVC sites
• Drive implementation of One Global Management system in HVC, developGlobal procedures for key processes
• Define strategy for Global policy and Global Procedures
• Support the CQO in the implementation of strategies to monitor andimprove the level of regulatory compliance in HVC
• Ensure compliance tovariour regulatory requirements and create an effective oversight of other HVCentities
• Prepare HVC sites for theauthorities audits and support these audits as requried
• Develop and oversees market’s intelligence program at HVC and provides proactive gap assessment on competitors field actions and recalls, audits/483 observations, warning letters and other market actions; ensure proactive correction of identified gaps in HVC entities
• Drive the standardization of practices across HVC through theestablishment and maintenance of a global quality manual
• Own e-QMS platform
• Lead the project of the new e-QMS system implementation and ensuresucceseful implementation and transition in all HVC sites
• Develop and maintain a training platform and associated content onquality and regulaotry compliance
• Manage Global Internal audit program, coordinate Hoya Corporationaudits and external audits in the sites and provide support for external auditsas requried
• Collect, organize, and analyse quality and other indicators related tothe compliance of products, processess, and report on the conclusions andrecommended actions through management review meetings
• Prepare and lead Global CAPA review Board
• Manage Global Management reivew and ensure compliance of sitemanagmenet reviews
• Act as FSCA Gatekeeper, coordinate the Field Safety Corrective Actionassessment process and where required, the execution of Field Safety CorrectiveActions
• Oversee ISO 13485 certification program at HVC globally
• Support Legalmanufacturer activities as required (e.g. develop Quality agreements, overseeoutsourced activities)
• Act as a certified independentauditor (with registration in IRCA) and support Hoya Corporation audit programof other Hoya divisions.
• Manage and develop team

Requirements

Experience

• 10-12 years ofexperience in Regulatory compliance, Quality Assurance or Quality Systems inregulated industry (pharma or medical device)
• Must have managedexternal audits of Notified Bodies, & preferably FDA
• Must have monitoredproduct quality in production or in the field
• Strong knowledge ofQMS requirements and quality and regulatory compliance.
• Strong knowledge ofISO13485 and other regulatory requirements such as PMDA, US FDA and othercritical regulators
• ISO 13485 certifiedlead auditor with experience in establishing and lead Internal audit program.
• Min 5 years’experience of managing team

Skills/Accreditations

• Staffing skills,Strong Leadership and People skills
• Project Managementskills (both written and oral)
• ExcellentCommunication and Presentation skills
• Able to lead andmotivate cross-functional teams
• Budgeting process
• Analytical skills thatdemonstrate the ability to recognize when system or staff adjustments areneeded
• Proficient inMicrosoft office, Excel spreadsheet, process mapping, flowcharting, databasesystems
• Knowledge of Power BIand AI tools is a plus
• Quality Orientation,Continuous improvement, technical and professional knowledge and skills inQuality Assurance, Quality System Management and Compliance
• Adaptable, willing to coachand develop others
• Able to make decisions,resolve conflict, and influence

Academic Qualifications

• Degree in Engineering, Quality, or equivalent technical experience
• Formal education in Quality Management preferred
• Auditor certification by IRCA as a plus

Travel requirements

• Up to 35%, mainly to Thailand, Japan, Europe, and USA