Immunology Product Quality Senior Director

Immunology Product Quality Senior Director

bioMérieux

Marcy l'Etoile, France

What will be your responsibilities within bioMérieux?

This position under the supervision of the SVP pre and postmarket quality, is accountable of 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. The quality product senior director will also be in charge of issuing the Post market quality reports defining if the product is still state of the art and if any support post launch is needed. He provides 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. He is also in charge of keeping up with bioMerieux growing market and product lines, and the ever-evolving global quality landscape.

The senior director will 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).

The manager will manage an operational team of almost 20 people with 4 direct reports including 2 managers and 2 single contributors). The 2 managers will be in charge of, on one side postmarket quality activities such as vigilance and field actions and, one the other side premarket quality activities such as the support of the development of new products and product life cycle management. The 2 single contributors will be in charge of risk management for the product range and postmarket surveillance reports. The team will be mainly based in France but also in the US and in Firenze.

Through the use of strategic thinking, study design expertise, and an ability to navigate and align stakeholders, the senior 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. The senior director is a key contributor.

The Immuno assay business is focusing on Vidas system (instrument, software and reagents). Revenues ca. 350 M€ , 3 sites (2 in France, Italy), around 250 references.

Who are you?

Studies-Experience:

  • Master’s degree or equivalent in Science or Engineering;
  • 10+ years in quality vigilance/field actions and or design control, or equivalent, medical device/IVD industry preferred;
  • 5+ years leading projects and directly managing other employees;
  • Excellent verbal and written communication skills;
  • Fluent communication in English.

Skills and Qualifications:

  • 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 work both independently and in a team environment;
  • 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.

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