World leader in the field of in vitro diagnostics for over 50 years, bioMérieux conceives, develops, produces and markets diagnostics solutions (systems, reagents, software and services) intended for clinical and industrial applications, which determine the origin of a disease or a contamination toimprove the health of patients and insure consumer safety.
bioMérieux is present in over 150 countries through 43 subsidiaries and a large network of distributors. More than 90% of our sales are done internationally. Its corporate headquarters are located in Marcy l'Etoile, near Lyon, in France.
Joining bioMérieux, is choosing to join an innovative company with a long term vision, committed tothe service of public health and carried out with a humanistic corporate culture.
We look for candidates whose motivation is to invest in themselves, in the projects of the future, and toparticipate in a collective adventure led by a pioneering spirit.
We have the commitment to offer our collaborators a working environment which encourages team spirit, with priority given to training and development with international career opportunities.
Our Group offers numerous possibilities: so come and join the 10,000 bioMérieux employees who have already identified with these values!
Astute Medical, Inc., a Biomerieux subsidiary, is an in-vitro diagnostics company dedicated to improvingthe diagnosis of high-risk medical conditions through the identification and validation of protein biomarkers that can serve as the basis for novel in-vitro diagnostic tests. To support thecommercialization of its novel biomarker products, including the FDA-cleared, CE-marked NephroCheck® Test for acute kidney injury, Astute Medical is seeking an energetic Senior Director, Quality Assurance.
Reporting to the Vice President Clinical & Regulatory Strategy, Senior Director of Quality Assurance has primary accountability of all aspects of Astute's Quality efforts such as developing and administrating Astute's Quality Management System (QMS), training and coaching employees, and facilitating change throughout the organization. Responsible for establishing strategy, policies and procedures at all levels so quality improvement efforts will meet internal and external customers' needs and expectations.
- Lead Company's corporate Quality Assurance function, with direct management responsibility forthe staff and accountability for ensuring that this team has the technical and professional skills, organizational structure, capacity, and business processes in place to maximize the value ofAstute's QMS;
- Manage and monitor the QMS in accordance with applicable federal, state and international regulations (e.g., 21CFR820 and IVDR) and standards (e.g., ISO 13485, ISO 14971, GMP requirements) to ensure its continuing suitability, adequacy, and effectiveness, including assessments of opportunities for improvement and need for changes;
- Keep abreast of the evolving regulatory policy and industry best practices related to in vitro diagnostics in the US and internationally, leading the evolution of Astute's QMS, as appropriate;
- Develop business cases for proposed investments and changes in systems, processes, staffing, and organizational development for Quality Assurance, providing clarity on costs, benefits, alternatives, resource requirements, and other relevant information to enable timely, effective decision making;
- Identify and suggest functional improvements to the Document Control and Quality Assurance organizations to further ensure regulatory compliance and constant inspection readiness;
- Collaborate with functional areas to establish and update metrics that are reported to upper management that highlights risks and key opportunities for continuous quality improvement;
- Provide Quality Assurance input on manufacturing, quality control, and product development processes to maintain compliance with the relevant quality regulations and international standards;
- Provide Quality Assurance input and resources to author, review and finalize quality related documents for regulatory submissions globally, including 510(k) and CE-IVD;
- Host FDA / third party regulatory inspections/audits, as needed, and ensure follow up on findings/observations issued including issuing CAPAs, as needed;
- Ensure budgets, schedules, and department performance requirements are met;
- Ensure Quality Assurance representation in all phases of IVD product development: concept, feasibility, design and development, verification and validation, manufacturing transfer, and commercialization - author quality plans and reports;
- Ensure compliance with calibration and validation requirements for the facility;
- Ensure compliance of Astute 's electronic document management system (EDMS, Master Control)with required regulations; including EDMS system implementation and maintenance, validation ofchanges to the system, and training of other employees;
- Ensure compliance with Company's QMS and ensure that all individuals reporting to him/her comply with the Company's QMS;
- Other duties as assigned.
- BS degree (or higher) in the physical sciences, life sciences, or engineering disciplines (physics, chemistry, chemical I biomedical engineering, biochemistry, or biology) or equivalent;
- 10+ years in medical device/ IVD field, with responsibility for a broad spectrum of Quality System elements and 4+ years management responsibility for QA personnel, preferred, however, other experience may be acceptable;
- In-depth knowledge of and demonstrated experience with leading cross-functional teams through development, implementation, application, and maintenance of Quality Systems which comply withFDA QSR, GMP, and related US and international regulations and ISO standards pertaining to IVD development and ongoing commercial manufacturing and delivery;
- Successful track record of selecting, implementing, and optimizing electronic quality management system software including modules for document control, complaints, nonconformities, CAPA, and other Quality System functions;
- Exceptionally strong team leader and team player with excellent interpersonal and communication skills, and experience working with end-users in a coaching capacity;
- Experience developing and managing departmental operating and capital budgets;
- Extremely detail-oriented with strong organizational skills and high quality standards;
- Excellent relationship building and persuasion skills with the ability to motivate and influence others; demonstrated record of overcoming resistance to change, and driving the adoption ofnew processes from a position of indirect or informal authority;
- Self-motivated, hands-on critical thinker and problem solver, with the ability to lead by example,with an enthusiastic, optimistic outlook, and a collaborative style;
- Ability to integrate and apply feedback in a professional manner;
- Holds self and others accountable for adherence to high work and ethical standards;
- Ability to travel as required (up to 20% domestic and international), preferred;