Executive Director, Business Development & Strategic Program, Quality Management

at  Olympus Corporation of the Americas

JOB DESCRIPTION

The Executive Director, Business Development Quality will organize and oversees Quality, Regulatory Affairs and Compliance activities in support of Business Development process. This role would be responsible for orchestrating and execution of due diligence activities, deal assessment, remediation, and integration planning for potential business development opportunities. These may include a range of potential deals ranging from technology development agreements and distribution deals to full acquisition of small, medium, or large operating businesses and integration of those into Olympus operating environment. The role would be responsible for identification and assessment of risk, estimation of resources and funding required to remediate and integrate and ultimately for a recommendation to the business. This role will lead a BD Quality Organization and will work within the broad global Quality organization to ensure that appropriate experts from the broad organization participate in assessment and integration planning and ensuring that smooth integration into Olympus Quality System occurs.
The following roles will report into this role directly: Director Business Development Quality, Director, Business Director Regulatory Affairs, Sr. Manager Business Development Quality, Sr. Quality Auditor.
This role will be responsible for development of the BD/Integration Quality Plans, resourcing, and execution of those plans to completion and ultimately for Quality and Compliance operation of the acquired entities or BD deals.
The Executive Director, Business Development Quality 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, Legal and others to ensure the Quality strategy and operating objectives of the Business Development organization are designed in support of the company’s Quality/Compliance objectives.

APPLICANTS WITH DISABILITIES:

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Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs (QA/RA

• The ED, Business Development Quality, will focus on building and developing the following key competencies and processes:
• Ensuring that a BD playbook and other functional infrastructure is developed and continuously improved ensuring thorough and risk-based approach to the BD activities.
• Act as the primary point of contact between Quality/Regulatory Affairs and BD for all BD related activities and projects.
• Developing and execution of the Quality Plans in support of BD activities.
• Resource and financial assessment of integration timing and resulting expenses.
• Evaluation of risk (Quality and Compliance) associated with each BD activity and ultimate recommendation to the BD organization regarding each BD action.
• Building and maintain strong linkage with the Olympus organization within Quality and across other functions.
• Development and execution of post deal Integration Quality plans.
• Design and implementation of effective Quality System for acquired targets aligned with the Olympus Quality Management System.
• Develop strong and transparent KPIs to monitor Quality and Compliance performance across all acquired entities.
• Maintaining a clear view of Olympus standards of QARA and represent their consolidated view on QARA standards of each target to functional leadership as part of pre-deal planning.
• Develop and maintain a Business Development Playbook
• Manage and develops Quality organization in support of Business Development activities.
• Develop and execute Quality Plans to support early BD and Integration activities.
• Complete and communicate risk assessments based on Quality, Compliance, Timing and Funding impacts for Business Development activities.
• Manage and ensure audit readiness for acquired entities until their transition into baseline Olympus operations.
• Orchestrate and complete integration activities in coordination with all relevant functions within the Olympus organization.
• Tracks and improve Key Quality and Compliance Indicators for acquired entities.
• Assess, Design, and Develop Quality organizations for acquired entities to ensure strong focus on Safety, Quality and Compliance.
• Represent Quality on BD leadership teams.
• Set and improve Quality Culture and Mindset across acquired entities to ensure cohesive transition into full integration of those into Olympus operations.