About The Role
The Director Quality System and Regulatory Compliance is responsible to support CQO with the implementation of strategies to develop, implement, and maintain the quality management system (QMS) across HOYA Vision Care entities (HVC), and improve the level of quality and regulatory compliance in HVC.
This position also owns the global inspection readiness program, oversees the global ISO13485 certification, and creates an effective oversight of HVC entities QMS performance (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.
Major 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 HVC sites
- Define requirements to QMS documents across HVC sites
- Drive implementation of One Global Management system in HVC, develop Global procedures for key processes
- Define strategy for Global policy and Global Procedures
- Support the CQO in the implementation of strategies to monitor and improve the level of regulatory compliance in HVC
- Ensure compliance to variour regulatory requirements and create an effective oversight of other HVC entities
- Prepare HVC sites for the authorities 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/483observations, warning letters and other market actions; ensure proactive correction of identified gaps in HVC entities
- Drive the standardization of practices across HVC through the establishment and maintenance of a global quality manual
- Own e-QMS platform
- Lead the project of the new e-QMS system implementation and ensure succeseful implementation and transition in all HVC sites
- Develop and maintain a training platform and associated content on quality and regulaotry compliance
- Manage Global Internal audit program, coordinate Hoya Corporation audits and external audits in the sites and provide support for external audits as requried
- Collect, organize, and analyse quality and other indicators related to the compliance of products, processess, and report on the conclusions anrecommended actions through management review meetings
- Prepare and lead Global CAPA review Board
- Manage Global Management reivew and ensure compliance of site managmenet reviews
- Act as FSCA Gatekeeper, coordinate the Field Safety Corrective Action assessment process and where required, the execution of Field Safety Corrective Actions
- Oversee ISO 13485 certification program at HVC globally
- Support Legal manufacturer activities as required (e.g. develop Quality agreements, oversee outsourced activities)
- Act as a certified independent auditor (with registration in IRCA) and support Hoya Corporation audit program of other Hoya divisions.
- Manage and develop team
Qualifications
Academic Qualifications
- Degree in Engineering, Quality, or equivalent technical experience
- Formal education in Quality Management preferred
- Auditor certification by IRCA as a plus
Experience
- 10-12 years of experience in Regulatory compliance, Quality Assurance or Quality Systems in regulated industry (pharma or medical device)
- Must have managed external audits of Notified Bodies, & preferably FDA
- Must have monitored product quality in production or in the field
- Strong knowledge of QMS requirements and quality and regulatory compliance.
- Strong knowledge of ISO13485 and other regulatory requirements such as PMDA, US FDA and other critical regulators
- ISO 13485 certified lead 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 Management skills (both written and oral)
- Excellent Communication and Presentation skills
- Able to lead and motivate cross-functional teams
- Budgeting process
- Analytical skills that demonstrate the ability to recognize when system or staff adjustments are needed
- Proficient in Microsoft office, Excel spreadsheet, process mapping, flowcharting, database systems
- Knowledge of Power BI and AI tools is a plus
- Quality Orientation, Continuous improvement, technical and professional knowledge and skills in Quality Assurance, Quality System Management and Compliance
- Adaptable, willing to coach and develop others
- Able to make decisions, resolve conflict, and influence
Mobility
Willingness to travel up to 35%, mainly to Thailand, Japan, Europe, and USA.
