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Sr. Manager, North America QMR and Regulatory Affairs

Location: Salt Lake City, United States
Position Type: Unfixed Term
Job Function: Quality

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.

 

Position Summary:

  • Responsible for the Management of Quality and Regulatory team in North America (US and Canada)
  • Execute Quality, Regulatory, Vigilance and HSE strategies; ensure adherence to policies and drive implementation of the regulatory processes as planned at Project/Program level.
  • Accountable for Regional Quality objectives, you lead programs at the subsidiary for developing, implementing and continually improving systems to ensure customer requirements are implemented into company processes and services provided.
  • Ensure an efficient cluster Quality Management System is established in compliance with Corporate and external requirements (e.g. applicable standards and regulations, Distributors management).
  • Accountable for the maintenance and compliance of the Quality Management System of the North America (US and CANADIAN SUBSIDIARIES, and DISTRIBUTORS IN North America) with applicable requirements to ensure that customer expectations are met.
  • As Vigilance contact you will be responsible for managing the Vigilance activity and be the contact for the Canadian Competent Authorities on FSCA and Incident decisions.

 

Main Accountabilities:

Responsible for the Management of Quality and Regulatory team in North America:

  • Select new QMR in case of open position and develop quality competencies for local QMRs in the Region,
  • Make sure that resources necessary to accomplish the objectives are raised to GM / Cluster VP.
  • Provide expert advice and support to the QMRs and team within the subsidiaries (US, Canada)

 

Responsible for QUALITY in the Region:

  • Implement corporate quality policy in the Region
  • Implement quality objectives in the Region: Communicate, share, contribute to Corporate Quality Objectives, defining and reporting company KPIs as required
  • Define and Implement quality objectives for the Region.
  • Define and ensure appropriate quality training for the Region (newcomers & yearly training plan): make sure quality training needs are identified, quality training plan is established and followed-up.
  • Inform staff of new procedures and effectively checking that they are implemented with sufficient training.
  • Make sure processes needed for the Quality Management System are described and their performance is regularly assessed via a documented quality management review process
  • Manage external and internal audit processes to ensure inspection readiness, Identify audit needs, establishing internal audit schedule, allocate resources (including qualification of internal auditors), and follow-up.
  • Ensure "complaint handling process" is in place and effective in the Region
  • Manage the Region CAPA process
  • Manage documentation using global document management tools
  • Manage change management process for the Region.
  • Manage customer satisfaction surveys
  • Responsible for supplier approval for the Region, assuring continued supplier qualification
  • Manage Field Actions (FCA/FSCA/MAR/PSS/PRS)
  • Responsible for schedule management review, organize, coordinate collection of data from process owner and prepare management review, analyze the data, summarize and prepare the output from management review, and submit for approval to the head of the region

 

Responsible for the Management of the Distributors in the Region, for the Quality topics:

  • Accountable for training the distributor on Quality topics (Vigilance, complaint, Field action, ISO 9001, Audits,…)
  • Monitor their activities, via regular audit, KPIs, process review and regular calls
  • Gather local regulation and raise the requirements to global QA RA
  • Support the business and ensure compliance to standard and regulation, at distributor level

 

Responsible for vigilance in Canada (adverse events reporting, FSCA Reporting):

  • Monitor the local regulatory environment, including Vigilance regulation
  • Responsible for reporting to authorities (Incidents and FSCA), and communication with customers, third parties and authorities where required regarding quality.

 

Responsible for Regulatory Affairs in Canada, in coordination with Global RA:

  • Assess continuously Project output with consideration to evolving regulations; assess impact on resources and launch dates; adapt regulatory strategy and give feedback to Project,
  • Support regulatory processes to ensure timely execution (submission of registration files done by Global Regulatory Affairs team in contact with the distributors).
  • Assist in the development of answers to questions and in the interactions/negotiations with regulatory agencies of their representatives; review progress and report on issues,
  • Provide feedback on the effectiveness of the regulatory processes (strategy, applications review with questions/answers, issues and problem resolution) and contribute to improvement plan.
  • Determines compliance status to regulations and standards of operating departments and recommends corrective/improvement actions.

 

Studies and Experience:

  • Bachelor’s degree in Science or Engineering,
  • Knowledge of quality, vigilance and regulatory requirements, guidance documents and processes (local/regional) with more than 5 years of practice in the field of IVDs/MDs in a regional environment,
  • Knowledge of QMS requirements (QSR and/or ISO 13485 / ISO9001 and/or local GMPs if appropriate) with knowledge of design and change controls,
  • Familiar with product profiles and technology, company organization and processes,
  • Familiar with local regulatory agency organization (FDA, Health Canada),
  • Participation in local professional/trade organizations.

 

Skills and Qualifications:

  • 5 years experience in quality and in management
  • Good leadership and communication skills;
  • Ability to work both independently and in a team environment.
  • Be able to convince surrounding managers of added value of QM System,
  • Excellent verbal and written communication skills.
  • Ability to analyze and use data to drive decisions and process improvements.
  • Mobility: Travel as needed (external meetings, trainings)
  • Experience in participation in the management of regulatory audits (i.e. ISO 9001, 13485, FDA,  etc.);
  • Knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, CSA, VDE, etc.).

 

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.

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