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.
bioMerieux has a position open for a Global Investigation Leader to be based in Philadelphia, PA.
Within the Global Industry Customer Service (GiCS), the Global Investigation Leader is responsible of Complaint Handling Process, training material preparation and go to market. It includes the management, the coordination and the accountability of the end to end investigation. This role, shared with Quality department, will also enable the person to participate to the Quality operational activities of the manufacturing site.
What will be your responsibilities ?
- Provide technical support to subsidiaries and distributors on different system ranges intended for Industry Food Customers
- Be responsible and lead the investigations of concerned range of products
- Coordinate with various cross-functional teams within the organization including QA, QC, Manufacturing, Logistics and R&D to investigate incoming enquiries.
- Track/report the status of investigations and escalate concerns to management in a timely manner and make decision/action plans for resolution.
- Be THE referent in case of audit and lead the audit preparation – 1st line of contact in case of audit.
- Perform complaint trend analysis and prepare reports for other departments.
- Coach subsidiaries/distributors on support desks activities and troubleshoot at customer sites or remotely if necessary.
- Develop and adapt the support tools for subs and distributors to use in the support of customers (troubleshooting, guide, FAQ, KPI, Trend analysis, training materials and customer documentation…)
- Provide feedback on product/service issues to R&D, manufacturing and the PMO team
- Contribute to the design of support tools for subs/distributors to use in the support of customers (troubleshooting, guide, FAQ…).
Who are you ?
- BA/BS in Biology, Molecular Biology, Microbiology required with 3 years industry experience or MS with 1-2 years of industry experience
- Ideally, experience in participating to regulatory audits (ex: FDA, ISO, OSHA, EPA etc.)
- Hands on experience with PCR and laboratory techniques preferred
- Exposure to Quality and Manufacturing field required with knowledge of Quality Management Systems, change control processes, non-conformances and deviations, root-cause investigations, implementation of CAPA
- You are recognized for your leadership, and your ability to convince and gain buy-in.
- Good communication skills, good team spirit, analysis and synthesis
- Committed to customer and to service with a sense of urgency and accountability.
- Knowledge in ERP functioning and reporting tools (SAP, CRM…)
- Must be proficient in Microsoft Office tools
- Must possess good technical writing skills for drafting investigation reports and other communications
- Cross cultural flexibility.
- French language is a plus
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.