Quality Manager, European Distribution and Commercial Operations
Clinical Division Group
Based in one of our European sites (Cressier, Watford, Bales, Marnes-la-Coquette,...)
Provides leadership, strategic direction, and results reporting regarding Quality Assurance Operations for Distribution Centers and Commercial entities located in Europe:
- Leads Distribution and Commercial QA teams in establishing, implementing and maintaining effective quality management systems (QMS). Directs the execution of effective QMS objectives to ensure that Bio-Rad products continue to meet quality, business, and QMS compliance requirements.
- Works closely with EU Logistic and GCO management teams to implement and execute quality and efficiency improvement objectives supporting logistic and distribution. Develops effective working relationships with Logistic/GCO management to clearly define and fulfill responsibilities within the quality management and continuous improvement areas.
- Responsible for the quality oversight of the products distribution. Supports changes in distribution network changes.
- Partners with Global RA teams to ensure that Distribution and Commercial QA teams support domestic and international complaint reporting requirements, including providing investigational and CAPA support for adverse events, field safety corrective actions, and other CAPA-related activities.
- Tracks meaningful QMS metrics to clearly and routinely communicate QMS strengths, weaknesses, opportunities and threats to European management. Similarly, holds effective Quality Management Reviews with Distribution/Commercial to monitor appropriateness of quality systems and processes to meet requirements.
- Partners with EU RA/QA management peers to continuously improve and harmonize QMS processes.
- Stays current on evolving QMS trends and requirements and develops QA team competency and excellence to manage change and continually improve.
Bachelor’s Degree or equivalent in Sciences/Medical Technology. Advanced degree preferred. Lean / Six Sigma or other continuous quality improvement certification preferred.
- Minimum ten years’experience in relevant industry experience, some portion of which must include a distribution and commercial environment of diagnostics medical device.
- Minimum of five years management experience.
- Internal Auditing experience
- Strong skills in leadership, negotiation, customer relationships.
- Committed, deadline and results driven.
- Knowledge of QMS requirements applying to medical devices / in vitro diagnostic products.
- Proven management skills and demonstrated ability to effectively communicate (written and oral) with individuals to attain desired goals.
- Ability to effectively manage remote teams, establish levels of responsibility, delegate appropriate authority, train, motivate and discipline the performance of subordinates in a manner conducive to proficient performance and high morale.
- Ability to create, anticipate changing needs, and adapt in a timely fashion.
- Fluent English (another EU language would be an advantage – French, German…)
If you feel attracted to this unique opportunity and you would like to take on new challenges, please send us your CV and your cover letter.