Executive Director, Global CAPA Process at Olympus Corporation of the Americas in Center Valley, PA
Are you looking for a company that cares about people's lives and health, including yours? At Olympus, we help make people's lives healthier, safer and more fulfilling, every day. Let's inspire healthier lives, together. Job Description The Executive Director, Global CAPA Management is responsible for developing and implementation of business strategies to effectively manage all Core QMS Issue Management processes (ref:
GPO #2), see below, including CAPAs, NCs, deviations, calibration, etc. on a global basis. The Executive Director will manage the Olympus CAPA Process and sub processes e.g., NCs, deviations, calibration in all Olympus Global Locations and have Management Responsibility for governing the CAPA process utilized globally and act as the top most CAPA review board. In addition, the Executive Director of Global CAPA management will manage a small organization at the global level to manage Global CAPAs. This role will extensively include strategic planning and direction with regional, local operational support & oversight as needed. Global Process Owner (GPO) #2 global QMS process
Responsibilities:
Job Duties Ensure the proper execution of the Global CAPA process and sub processes within GPO #2. Ensure the proper management of the Global CAPA organization and GPO #2. Lead the development of the Future State of the Global CAPA process and organization. Manage the GPO #2 and Global CAPA functions Budget and Headcount. Manage the relationship with IT as it relates to the collection and processing of CAPA and sub processes. Act as global SME as it relates to all things CAPA. Lead the organization that will represent the Olympus in Regulatory (global) Body inspections as they relate to CAPA management. Act as the most responsible global executive when it comes to communicating with Regulatory Authorities as those communications relate to CAPA management. Provide data to those internal organizations that require it to meet those organizations. Quality Management System requirements for Management Reviews or other ad hoc requests. Job Requirements REQUIRED QUALIFICATIONS Bachelor's Degree in Business, Engineering, Life Sciences, or related technical degree. Minimum of 8 years leading a global organization in medical devices at the director level or higher. Other Considerations (travel/hours availability, etc.):
Ability to travel up to 33% of time domestically and internationally. PREFERRED QUALIFICATIONS Strong Interpersonal skills. Ability to manage complexity, analytical, people management on a global basis, Office 365. Works well with different cultures. Works well dealing with regulatory agencies. Strong Executive Presence.
Salary Range:
$150K -- $200K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
GPO #2), see below, including CAPAs, NCs, deviations, calibration, etc. on a global basis. The Executive Director will manage the Olympus CAPA Process and sub processes e.g., NCs, deviations, calibration in all Olympus Global Locations and have Management Responsibility for governing the CAPA process utilized globally and act as the top most CAPA review board. In addition, the Executive Director of Global CAPA management will manage a small organization at the global level to manage Global CAPAs. This role will extensively include strategic planning and direction with regional, local operational support & oversight as needed. Global Process Owner (GPO) #2 global QMS process
Responsibilities:
Job Duties Ensure the proper execution of the Global CAPA process and sub processes within GPO #2. Ensure the proper management of the Global CAPA organization and GPO #2. Lead the development of the Future State of the Global CAPA process and organization. Manage the GPO #2 and Global CAPA functions Budget and Headcount. Manage the relationship with IT as it relates to the collection and processing of CAPA and sub processes. Act as global SME as it relates to all things CAPA. Lead the organization that will represent the Olympus in Regulatory (global) Body inspections as they relate to CAPA management. Act as the most responsible global executive when it comes to communicating with Regulatory Authorities as those communications relate to CAPA management. Provide data to those internal organizations that require it to meet those organizations. Quality Management System requirements for Management Reviews or other ad hoc requests. Job Requirements REQUIRED QUALIFICATIONS Bachelor's Degree in Business, Engineering, Life Sciences, or related technical degree. Minimum of 8 years leading a global organization in medical devices at the director level or higher. Other Considerations (travel/hours availability, etc.):
Ability to travel up to 33% of time domestically and internationally. PREFERRED QUALIFICATIONS Strong Interpersonal skills. Ability to manage complexity, analytical, people management on a global basis, Office 365. Works well with different cultures. Works well dealing with regulatory agencies. Strong Executive Presence.
Salary Range:
$150K -- $200K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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