Sr Specialist Quality & Regulatory Compliance

Position Summary:

As a Senior Specialist-Quality and Regulatory Compliance, you will support bioMérieux US Commercial Operations efforts to develop, implement, and improve systems while ensuring customer satisfaction. Assist business owners with defining processes and measuring performance of those processes.  In this role, you will support efforts to ensure organizational compliance with government regulations and applicable standards (FDA QSR, ISO 9001 and 13485, and other applicable country specific regulations) and ensure services are developed and delivered that meet quality requirements.

Primary Responsibilities:

• Support assessments of the quality system for compliance (ex: customers, FDA, and ISO Registrars). Ensure such assessments are conducted in accordance with established policies and procedures. Define actions required to maintain the compliance of the Quality System according to company and regulatory requirements.
• Lead audits and support the development and implementation of corrective actions arising from the audit findings.
• Participate in the CAPA/NC/Waiver process for US Commercial Operations including owning or performing QA review of CAPA/NC/Waivers as assigned.
• Quality reviewer for Customer Material related to US Commercial Operations. Provide leadership to initiating and approving departments including, but not limited to, Marketing, Customer Education, Customer Support, etc.
• Lead the Field Actions process for the US. Support the process as needed to meet global objectives for Field Action completion.
• Participate in the document control process for US Commercial Operations. Write and revise operative procedures and process documents where necessary. Ensure that written procedures are maintained to define the specifications and procedural requirements of the quality system and that effective change controls are maintained to assure that any changes are thoroughly reviewed and shown to be appropriate.
• Define, develop, and implement quality and compliance training programs that provide the necessary skills and knowledge needed by Commercial Operations personnel to achieve company and regulatory objectives including compliance.
•  Advise employees on quality/ regulatory elements and process improvements. Encourage personnel to take initiative, to be proactive, and to strive to improve their work and the processes that shape their work.
• Assist the functional areas in identifying the appropriate actions and opportunities to meet and exceed objectives. Lead or facilitate teams to accomplish these deliverables, milestones, and objectives.
• Determine appropriate KPIs and benchmark levels for key quality indicators. Establish, maintain and improve reports of quality data, such as the quality scorecard, to assist in the continuous improvement of quality and business maturity. This data is to be included in monthly reports and the QSMR.
• Ensure regulatory compliance of North America bioMérieux subsidiaries: It is through regulatory compliance that QA/RA ensures business continuity. It is the first and essential requirement that allows us to support commercial activities. Any lack of regulatory compliance has an impact and may jeopardize partially or completely business activities. In addition, regulatory compliance is essential to accomplish our responsibilities and commitment towards our customers and public health.Ensure support of commercial activities through: Evaluating regulatory requirements needed to register and launch new products in new regions, renewal of existing permits and authorizations, active implementation of a Quality Management System and a culture of Quality within North America bioMérieux subsidiaries to facilitate operations and to ensure customer satisfaction.
• Maintain a Quality Management System that adheres to MDSAP, ISO 9001, and ISO 13485 and ensure execution of the bioMerieux Quality Policy.

Education and Experience Required:

• Bachelor’s Degree required. A Life Sciences or Engineering degree preferred.

• 8+ years of experience in quality required.

• 15+ years of healthcare experience will be accepted in lieu of a degree