General Electric Total Quality Leader- Cell & Gene Therapy (m/f) in Eysins, Switzerland
Role Summary:This position will lead the development and execution of the total quality strategy for the C> manufacturing sites (Eysins & Cambridge) focusing on both compliance and product quality. It is responsible for driving total quality metrics for the business, including the Balanced Scorecard, QMS compliance and leading the total quality business reviews with Site and Senior Leadership.
Essential Responsibilities:-Shape the GE Healthcare total operational quality vision which translates into clear strategies and priorities for the Cell & Gene Therapy manufacturing sites.
-Responsible for site and business achievement of outcomes defined and measured by the designated quality metrics and reported on the standard site quality scorecard. Drive all site-level quality operating mechanisms and represent site along with site executive in global operating mechanisms.
-Ensure product quality is visible and actionable. Responsible for the planning, developing, directing and implementation of techniques to ensure the maintenance of quality levels in company’s products and production processes. Escalate issues, risks and deficiencies through quality, functional and operating teams where required to achieve adequate focus and attention.
-Prioritize Quality actions and uses a risk-based approach – Partners with Engineering, Manufacturing, Supplier Management and Service to determine ownership, priority, and resolution.
-Integrate closely with operations and engineering teams and staff as extended staff member and co-own Quality assurance and product quality with operating leadership. Coordinates with other sites in the same modality to ensure product issues and priorities, quality metrics are aligned, well-understood and addressed.
-Site’s point of contact to regulators. Ensure audit readiness is maintained and audit support is superbly executed. Serves as site’s management representative.
-Implement and adhere to the all applicable regulations at the site and ensure others do the same through education and training.
-Ensure day to day compliance – QMS, policy, regulatory. Stay abreast of industry Quality and Regulatory trends and developments.
-Create the total quality strategy for New Product Introductions (NPI) reviews; participate in NPI and Phase Review Discipline (PRD) reviews.
-Ensure conformance of devices is properly checked prior to final release, technical documentation for EU declaration of conformity are complete and maintained, post-market requirements are met, and reporting is completed as required. When applicable, ensures that investigational devices are handled as per required regulations.
-Support and aid in modality adoption of operational excellence improvements
-Oversee a team of Quality professionals who drive Quality throughout the various products designed and/or manufactured at the site.
-Provide visible people leadership for the organization including hiring and/or developing Quality Assurance and Product Quality personnel.
Qualifications/Requirements:Bachelor's Degree in medicine, pharmacy, engineering or other relevant scientific discipline and a minimum of 7 years professional experience in regulatory affairs or quality management systems relating to medical devices, fluent English and fluent French language skills
Desired Characteristics:Strong people leader – instill empowerment and trust within the organization
Change agent – drive & accelerate a Total Quality product culture
Influential leader – ability to work cross-functionally and drive wins for the business; collaborator
Strategic thinker – ability to stay out of the weeds and focus on the future state
Constructive conflict – not afraid to lean into tough conversations to get to the best outcome for the business
Demonstrated knowledge of the Quality Management System (9001/13485)
Able to react with appropriate urgency and professionalism ; make decisions under pressure
Strong business acumen – uses financial analysis to make important business decisions understands key financial metrics, can articulate the company’s business vision key business objectives, understands business trends and cycles.
Ability to handle competing priorities effectively
Master’s degree in Business or other related area
Black Belt or Master Black Belt
About Us:GE (NYSE:GE) drives the world forward by tackling its biggest challenges. By combining world-class engineering with software and analytics, GE helps the world work more efficiently, reliably, and safely. GE people are global, diverse and dedicated, operating with the highest integrity and passion to fulfill GE’s mission and deliver for our customers. www.ge.comAdditional Locations:Switzerland;Eysins;
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