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Vice President, Regional Quality Business Partner, Quality Management
2 weeks ago
**About the Role**:
The Vice President, Regional Quality Business Partner, Quality Management (“VP RQ”) will be based in a specific Region and assigned to support the leadership (RRO and ExCom team) within that geographic region. The position reports to the Quality Function, to the SVP Corporate Quality but maintains a dotted line relationship to the RRO in the region served and will be a member of ExCom in some regions.
The key accountability for this role is to work bi-directionally; representing Global Quality within the Region and representing the needs and nuanced requirements of the Region to the Global Quality organisation. Global Quality is organised into global pillars, which are represented operationally in the region by other leaders (e.g., at Director level) who themselves report outside of the Region to Global pillar leaders. The VPRQ is charged with integrating these services locally in each region and to provide a “one stop shop” for operational Quality needs locally. The role requires the co-ordination of Operational (plant) Quality, Post Market Quality, R&D Quality, Corporate QMS, CAPA etc. requirement to provide a seamless and efficient services locally.
Where QMS elements are harmonised, with permitted local variation the VPRQ is responsible for ensuring the local variations are recognised and approved by Global pillar owners within the Quality Leadership (e.g., Design Assurance, Post Market, Distribution, Product Quality etc) and are legal, compliant, and industry standard within the region in question.
On an ongoing basis the role would be responsible for pro-active identification and assessment of risks, business continuity threats and estimation of procedural changes, resource requirements and funding required to mitigate these and representing these needs to the Global Pillar owners and QARA leadership, assessing the true need for local variation and supporting that to QARA leadership. This role will be seen as the “go to” Quality leader in a region and will ensure frictionless interaction with the Quality organisation at a regional level. Simplification and Efficiency should be the operational touchstones and all elementsfrom Notified Body strategy to resourcing and approach to compliance should be considered in scope in achieving this.
The role will have accountability for the effective operation core corporate functions within the Region and will hold a dotted reporting line accountability with all Quality pillar regional leaders. The VPRQ will develop local functional ways of working to ensure effective delivery of the Quality strategy elements within the RROs scope of accountability.
The VPRQ will work closely with other functions within and outside of the Quality and Regulatory organizations such as Operations, Service/Repair, R&D, Post Market Quality, Medical Affairs, HR, Legal, Finance and others to ensure the Quality strategy and operating objectives of the Business Development organization are aligned in support of the company’s Quality/Compliance objectives and those of the RRO and ensuring compliance with local law where that varies from Region to Region.
**Primary Responsibilities**
The VPRQ will focus on building and developing the following key competencies and processes:
- Ensuring that Quality is seamlessly represented locally in the region.
- Act as the Quality primary point of contact for the RRO
- Represent the needs of the region to QARA leadership
- Developing and execution of the Quality Plans in support of Regionalisation of Global activities.
- Evaluation of risk (Quality, Compliance & Business Continuity) associated with each regional activity and ultimate recommend to the QARA leadership and RRO the appropriate way forward.
- Building and maintaining strong linkage with the Olympus organization within Quality and across other functions, reflecting regional nuances outside of Quality that impact the operation of the Quality function locally.
- Development and execution of Quality plans to address gaps.
- Implementation of effective Quality System for the Region aligned with the Olympus Quality Management System, but defining and approving truly necessary “Harmonisation variances”.
- Develop a strong regional team (dotted line + solid line together) and drive transparent KPIs to address Quality and Compliance performance needs all regional sites and entities.
**About Olympus**:
Our purpose at Olympus is to **_make peoples’ lives healthier, safer and more fulfilling_**. We do this through innovation. As a technology pioneer, we design and deliver solutions across our Medical division that makes a positive contribution to society.
Our products are used to capture the medical and diagnostic images of our world, from the microscopic to the endoscopic. They are instrumental for traveling inside the human body to help diagnose, treat and prevent illness.
Our commitment to customers and our social responsibility is the cornerstone of everything we do.
**
