A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux provides diagnostic solutions that detect disease and contamination to improve patient health and ensure consumer safety. In North America we have more than 5,000 team members across 12 sites or subsidiaries, including Salt Lake City based BioFire Diagnostics. We believe in the power of diagnostics and bioMérieux sponsors public health initiatives and partnerships to address antimicrobial resistance, sepsis awareness, food safety, and consumer health across the globe. Come be a part of our mission to help save lives.
This position leads the Salt Lake City – Murray facility efforts to develop, implement, and continually improve Quality Systems to ensure customer requirements are implemented into company products and services provided. Ensures operational compliance with applicable government regulations (FDA-Quality System Regulation, Canadian-Medical Device Registration, IVD Directive and other applicable country specific regulations) and applicable quality standards (MDSAP, ISO-9001, ISO-13485, etc.), and enhances stakeholder value. Responsible to provide expert guidance to all levels (regarding tools, techniques, management systems) for Quality assurance, Quality control, compliance, Regulatory Affairs and continuous Quality improvement. Ensures products and services are developed, manufactured, tested, and delivered according to established procedures meeting Quality requirements. Position is also responsible to organize, lead, and develop the operations of Quality/RA. Contributes to the regulatory strategy for a new molecular Point of Care system, assist the development team and ensures that regulatory strategies and policies are understood, compliant and successfully implemented.
- Serve as the Management Representative for the SLC-Murray facility and provide the facility with regulatory expertise. Lead assessments of the Quality systems for compliance, ensuring such assessments are conducted in accordance with established policies and procedures to maximize their benefit to bioMérieux, Inc.
- Ensure that written procedures are maintained to define the specifications and procedural requirements affecting product Quality, and that effective change controls for processes & equipment are maintained to assure that any changes are thoroughly reviewed and shown to be appropriate, including review for their potential to affect validations or regulatory submissions.
- Develop and maintain the Corrective and Preventive Action programs including: necessary procedures, records, manuals, and trend reports. These programs lead to process, product and service improvements.
- Facilitate teams to accomplish the deliverables, milestones, and objectives meeting the plans and schedules ensuring that any changes to the plans are communicated and agreed to by the teams and project sponsors for the SLC-Murray site. This includes teams to develop and validate regulatory strategy, standardize processes at North America sites as well as implement corporate Quality system and Regulatory processes.
- Lead the development and implementation of Quality practices with regard to validation activities at the SLC-Murray site to ensure compliance with the requirements of the Quality System Regulation & Standards.
- Develop and implement Quality and Regulatory training programs that provide necessary organizational knowledge to achieve company objectives.
- Establish, maintain and improve reports of Quality/RA data to assist continuous improvement and assess the effectiveness of the facilities Quality system.
- Contribute to the regulatory strategy and execute regulatory process as planned
Experience & Skills:
- A minimum of 12 years of relevant industry experience required.
- Must have experience leading Quality and/or regulatory systems at a high level in a relevant regulated environment, including experience directly managing regulatory audits by FDA and ISO.
- Demonstrated competence in the selection and use of Quality Engineering tools, techniques, and processes.
- Expert knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, MDSAP, etc.).
- Certified Quality Engineering (CQE), Certified Quality Auditor (CQA) or Six Sigma Black Belt desired.
- Minimum four (4) years managing people across multiple Quality and/or RA disciplines.
- Must possess the ability to coordinate and communicate across departments and throughout all levels of the organization to ensure cooperation and alignment in Quality/RA objectives.
- Knowledge and good understanding of regulatory requirements, guidances and processes in the field of IVDs/MDs
- Ability to work in an entrepreneurial environment
Joining bioMérieux, is choosing to join an innovative company with a long term vision, committed to the service of public health and carried out with a humanistic corporate culture. Our Group offers numerous possibilities: so come and join the 13,000 bioMérieux team members who already identify with these values!
bioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity/GINA.