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Sr Director, Microbiology Product Quality

Location: Hazelwood, MO, United States
Position Type: Unfixed Term
Job Function: Quality

A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For almost 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 44 countries and serve 160 countries with the support of a large distribution network. This includes our SLC site, formerly known as BioFire Diagnostics.

Description

Position Summary:

We are looking for a Sr. Director, Product Quality who will evolve within the Quality department and will report to the Senior VP of Pre and Post Market Quality within a team of 12 co-workers. Through the use of strategic thinking, study design expertise, and an ability to navigate and align stakeholders, the Sr. Director will facilitate cross functional approaches to address identified product trends/issues and investigate to ensure proper reporting to executive management and regulatory agencies, continual assessment of benefit-risk ratios and product safety/effectiveness, as well as providing feedback for future development needs. 

Primary Responsibilities:

  • Accountable for the quality level of the product range throughout product lifecycle management starting with the support of the development of the product, approval of the product risk analysis files, management of vigilance and field actions activities.
  • Responsible for issuing the post market quality reports defining if the product is still state of the art and if any support post launch is needed. 
  • Provide visibility on the quality level of the product range to the top management and propose action to maintain it at the right level for our customers and patients. 
  • Responsible for keeping up with bioMerieux's growing market and product lines, and the ever-evolving global quality landscape. 
  • Ensure adherence to policies and drive implementation of the all quality processes especially product risk files, Product Development Process, assessment for potential adverse events, field actions and Post Market Surveillance, as well as compliance with Corporate and external requirements (e.g. applicable standards and regulations, Distributors management). 
  • Oversee the direction and development of the product quality team 

Education, Skills, & Experience:

  • Bachelor's degree in Science or Engineering 
    • 10+ years in quality vigilance/field actions, design control, or equivalent
    • 5+ years leading projects and directly managing other employees. 
    • Medical Device/IVD industry preferred
  • Excellent verbal and written communication skills. 
  • Demonstrate success in supporting both growth and product support projects, including complex projects involving ambiguity, in a rapidly changing regulatory and quality environment. 
  • Comprehensive knowledge of regulations applicable to medical device/IVD industry with an expertise on vigilance, field actions and design control ones. Must be able to interpret regulatory and quality requirements (QSR, IVDR, ISO 13485 / ISO9001 and/or local GMPs if appropriate). 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.). 
  • Ability to inspire, motivate, and build the confidence of teams to reach goals, consistently pushing self and others to achieve results. 
  • Ability to influence peers, higher leaders and external expert or regulatory bodies. 
  • Must demonstrate strong leadership skills 
  • Ability to analyze and use data to drive decisions and process improvements. Familiar with product profiles and technology, company organization and processes will be a plus. 
  • Ability to travel as needed 

#LI-US

Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMérieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site https://careers.biomerieux.com/ or contact us at [email protected].

BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).

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