QMR UK & Ireland, Vigilance contact
Basingstoke, GB
A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For more than 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health.
bioMérieux is present in 45 countries and employs nearly 14,000 people. In Asia Pacific, we have more than 1100 employees with presence in 10 countries.
Come and join a French family-owned global company with a long-term vision, and a human-centered culture.
Join us as the UKI Cluster Quality & Regulatory Affairs Manager, where you’ll lead the Quality and Regulatory team (2 direct reports) and ensure compliance across the UKI region. Reporting to the Sr Director EMEA Quality/Regulatory Affairs and functionally to the VP UKI Cluster, you’ll drive quality objectives, regulatory adherence, and continuous improvement.
Key Responsibilities:
- Lead and develop the UKI Quality & Regulatory team.
- Implement and improve the Quality Management System to meet corporate and regulatory standards.
- Act as primary contact for Competent Authorities and manage Field Safety Corrective Actions (FSCA).
- Oversee audits, compliance, and KPI monitoring for quality processes.
- Foster a quality-driven culture and strong customer focus.
About You:
- Life Sciences degree with significant industry experience.
- Strong knowledge of MHRA and ISO standards (ISO 9001, 14001, 45001).
- Proven leadership, analytical skills, and business mindset.
- Experience managing audits and regulatory compliance.
- Hybrid working model with occasional travel.
bioMérieux welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.