Executive Director, Quality - Americas

Job Description

The Executive Director, Quality – Americas, is responsible for quality operations at the Company’s manufacturing sites including management of site-based quality teams. Serve as the subject matter expert on CGMP requirements, ensuring that systems and procedures are in accordance with applicable laws and regulations. The Executive Director, Quality develops strategic and operational plans to ensure successful delivery. Defines innovative solutions within the most complex and ambiguous areas of the business. Leads other managers and provides strategic direction for the organization through a comprehensive understanding of the medical device regulatory space.

Job Duties

* Manage a team of quality management in the Americas in support of operational activities across multiple business units while implementing best practices.

* Leads the development and maintenance of facility Quality Management System and associated procedures and authorizes the implementation of these, ensuring alignment to Olympus company policies.

* Responsible for product quality oversight, management and escalation from a Quality perspective, to senior leadership.

* Develop, execute and maintain facility Quality Scorecard / Dashboard, ensuring performance levels attained deliver on expected target goals and demonstrate best in class performance.

* Responsible for site audit readiness and ensures adoption and compliance to all applicable regulatory standard requirements, guidance and best practices.

* Responsible for the identification, acquisition, development and retention of high performing Quality Talent, ensuring adequate and competent Quality resources are present as needed.

* Adhere to established Quality Management System and assist with development of new/improved QMS systems across business units.

* Provide input and support for the development, implementation, and improvement of QA processes.

* Collaborate with Design Assurance, Quality Engineering, Quality System and Process Validation teams to support accuracy and continuous improvement of product designs and documentation.

* Participates in investigations, assessments, and evaluations of quality records such as deviations, CAPAs, and change controls, as necessary.

* Supports the planning process to drive continuous improvements and changes of the Quality System to ensure on-going effectiveness, efficiency and sustainability.

* Partners with senior leaders across Olympus to identify and remove blockers to ensure delivery of an integrated approach to Quality across the business.

* Engage in a positive manner with team members from all disciplines to ensure common goals are being met (production, material handling, lean manufacturing, engineering, purchasing, safety, maintenance, shipping/receiving, customer service, etc.).

* Organize, direct, and delegate tasks as necessary to lead cross-functional teams through quality response efforts.

Job Requirements

REQUIRED QUALIFICATIONS:

* Bachelors or Masters degree in the Sciences or Engineering.

* Minimum of 15 years Medical Device experience with B.S. degree in Science, Engineering, Pharmacy or related technical field.

* Minimum of 12 years Medical Device experience with M.S. degree in Science, Engineering, Pharmacy or related technical field.

* Minimum of 5 years management experience.

* Knowledgeable about the science and manufacturing of medical devices.

* Extensive working knowledge of international GMP regulatory frameworks, regulations and guidance.

* Track record of successful project leadership and delivery within a matrix organization.

* Will work with global teams, availability will include working across the associated time zones. International and domestic travel up to 15% of the time.

PREFERRED QUALIFICATIONS:

* Excellent communication skills and relationship-building.

* Problem Solving, Technical Aptitude, Attention to Detail, Solution Oriented, Effective Verbal and Written Communicator, Quality Engineering Disciplines, Quality Control Disciplines, Quality Systems Disciplines and Strategic Leadership.