Executive Director, Global Quality Management System

Job Description

The Executive Director for Global Quality Management Systems Global (ED-GQMS) is responsible for management and strategic direction for implementation of the Olympus Global Quality Management System to ensure it is compliant with all relevant international standards and business requirements. Core global process direction includes document & record control, training, management review, data analysis & trending, and quality risk management.

The ED-GQMS collaborates with other functional and business leaders to establish, drive, and achieve divisional key business objectives as related to the GQMS. The successful leader will work at a Market, Region, and Olympus level to develop strategies, policies, procedures, monitoring systems and service standards to ensure effective implementation and achievement of the GQMS, which supports the company’s business units, multiple commercial regions and markets in the selling and distribution of Olympus product.

The ED-GQMS implements industry best practices, procedural harmonization and seamless quality system integration through development of robust processes and quality plans. Act as an ambassador of GQMS harmonization to share, develop, deploy and integrate strategic plans and practices across Olympus globally.

Actively drive the progress of Transform QARA to implement a GQMS including agility in effective and efficient use of resources and organizational structure across Olympus to meet business and quality/compliance objectives.

Job Duties

* Ensure the proper execution and resourcing plans for the GQMS. GQMS established and implemented in accordance with all relevant International requirements and must report on the performance of the quality system to the Company’s management at all levels.

* Ensure the proper management of the GQMS.

* Project lead the execution of Transform QARA with regards to the QMS and harmonized QMS processes.

* Report to management any deviations from project plans and risks to the business associated with QMS compliance.

* Act as global SME as it relates to all things “QMS”

* Effectively communicate and negotiate with Regulatory Agencies as needed.

* Support the organization that will represent the Olympus in Regulatory (global) Body inspections as they relate to Quality Management Systems .

* Provide data and KPIs to those internal organizations that require it to meet those organizations Quality Management System requirements for Management Reviews or other ad hoc requests.

* Develop and generate the reports and action plans for the Global Quality Management Review.

* Assures the absence of significant quality issues and regulatory compliance actions by global government agencies through the design and governance of robust, efficient, and consistent Quality Systems, internal and external audit programs, and inspection readiness programs. Assures appropriate leadership support to all Competent Authorities including PMDA, FDA, NMPA, etc. as well as Notified Body inspections.

* Mentors, manages and develops direct reports. Trains key personnel on quality policies, processes, and SOPs.

* Support the Design of Future State Organization with CQO and Leadership Team.

* Develop Roadmap for Future Harmonized processes in the Quality Organization and cross functional teams.

* All Other Essential Duties as directed.

Job Requirements

REQUIRED QUALIFICATIONS:

* Bachelor’s degree or equivalent and minimum of 10 years related experience and or training; or the equivalent combination of education and experience.

* Minimum of 10 years experience in medical device industry with extensive application and management of quality systems background is essential.

* Expert knowledge and application of the U.S. FDA QSR, EU MDR, Japanese PMD requirements as well as ISO13485, ISO14971, and other international Medical Device QMS regulatory requirements and the ability to educate and advise others on related subject matter.

* Candidate must have the ability to read write and communicate effectively in English is required; this requirement includes clear understandable speech and demonstrated comprehension skills.

* Since this is a Global role, the individual will be expected to schedule meetings that work for multiple time zones and well as 40% travel, domestic and international is expected.

PREFERRED QUALIFICATIONS:

* Strong interpersonal, analytical, and organizational skills are required.

* Strong understanding of problem-solving investigation and quality system verification techniques.

* Strong attention to detail and accuracy are required.

*  Experience training and/or mentoring others is required. Ability to create and deliver training to all levels within the organization.

* Must be able to demonstrate a working proficiency in operating a personal computer and to perform basic word processing/spreadsheet tasks using Microsoft Excel and Word applications.