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Quality Management Representative (QMR) - Medical Office, Regulatory & Clinical Affairs

Date: Feb 23, 2021

Location: Marcy l'Etoile, 69, FR Salt Lake City, UTAH, US Durham, NC, US Marcy l'Etoile, 69, FR

Company: bioMérieux

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. bioMérieux’s global headquarters is located in Marcy L’Étoile, France, and we have more than 11,200 team members in 43 countries. With our distributor network, we serve more than 160 countries. bioMérieux, Inc., our Americas division, has more than 4,000 team members across 12 sites or subsidiaries. With nearly 1,200 team members. bioMérieux, Inc. sponsors public health initiatives and partnerships to address antimicrobial resistance, sepsis awareness, food safety, and consumer health. Our passionate team members recognize the power of diagnostics and rally behind our mission to help save lives.

Scope of Position

  • Defines and executes the Quality System strategy for the Medical Office, integrates and develops processes that meet Business needs across the global Medical Office Organization (Medical Affairs, Companion Diagnostics and Public & Government Affairs) as well as Clinical Affairs and Regulatory Affairs (CARAT).
  • Accountable for Defining and Implementing the Quality Objectives and the Management review for the aforementioned named functions to carry out its mission.
  • Reports operationally to the VP, Pre-Market Quality and functionally to the Chief Medical Officer. 
  • Works with the Medical Office and CARAT to identify resource needs and assures that adequate resources are in place to maintain a high functioning Quality System within the Medical Office.
  • Support Inspection Readiness activities for the Medical Office and CARAT, and coordinates with manufacturing sites.
  • Implementation of GCP throughout the Medical Office and CARAT business processes
  • The location preferences by priority are: 1) Marcy, 2) Salt Lake City, 3) Durham

 

 

Responsibilities include:

  • Assimilate Medical Office processes into the Quality Management System
  • Support and animate continuous improvement for Medical Affairs contribution in Innovation, Product Development and Life cycle Management (e.g. PMS), as well as throughout the Clinical and Regulatory Affairs organization
  • Support strategic global initiatives within the Medical Office (e.g. Evolving Medical Affairs project) 
  • Develop Quality Objectives, implement and monitor related KPIs among Global Medical Affairs, Companion Diagnostics and Public & Governmental Affairs
  • Assist and support the development of Quality Objectives, along with monitoring the related KPIs among regional and country/local Medical Affairs
  • Lead the consolidation and scheduling of the Medical Office and CARAT Management Review or Process Reviews 2x / year
  • Animate the CAPA process throughout the Medical Office if/when needed, and act as the Quality approver
  • Act as the Quality representative and approver for SOP development and implementation, which may include animating document workflows for the Medical Office
  • Coordination and alignment with the Medical Officer Leadership team for applicable areas of responsibility
  • Define what Quality independence in Clinical Trials looks like (GCP).  Aligning with CA Management, develop and implement a risk based approach to improve the level of quality independence in bioMérieux clinical trial operations.  The risk based approach should consider both product compliance considerations as well as strategic business impact, to help implement and measure right first time trials. 
  • Perform GCP assessment with a focus on data integrity, identify any current gaps or improvements, align with CA Management to create any necessary action plans to address the findings, evaluate effectiveness of any implemented actions.
  • Contribute to BioFire Transition Plan to achieve one Quality program among the combined Medical Office groups
  • Support personnel qualifications and GCP compliance

 

Who are you?

  • Experience of at least 2 years in a clinical medical setting (e.g. hospital, healthcare network, clinical laboratory)
  • Five years’ experience operating in a Quality Management System
  • Five years’ experience supporting Clinical Trials, or Regulatory Affairs activities 
  • Five years of past experience in the healthcare sector industry (IVD industry experience a plus), in Quality or similar function
  • Experience with product Life Cycle Management is a plus
  • Ease with multicultural environment
  • Fluent in English (both oral and written)
  • Ability to take initiative, and be comfortable working both autonomously with minimal supervision and as part of a cross-functional team.
  • Rigorous and able to build relationship with internal stakeholders.
  • Demonstrate problem solving/judgment/conceptual and analytical thinking.
  • Progressive mind-set,
  • Able to innovate and demonstrate flexibility and evolve in a metrical environment
  • Behaves with honesty and integrity

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 11,200 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.

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