JobdescriptionSenior Quality Manager
As a pivotal leader within our client organization, you will serve as the Quality Management Representative for the site, providing strategic direction to the QA team and ensuring our operations remain at the forefront of industry excellence.
Responsability
* Strategic Leadership: Guide the QA team to drive compliance and operational excellence across all quality functions, including NC/CAPA, change control, risk management, and complaint handling.
* Operational Excellence: Partner with leadership and product segment managers to spearhead robust quality improvement initiatives and elevate overall performance.
* Culture Champion: Foster a high-integrity culture of quality and GMP awareness, ensuring the site consistently meets or exceeds global regulatory standards.
* Audit Management: Lead and coordinate all internal and external audits, serving as the primary interface for health authorities, notified bodies, and key customers.
* QMS Evolution: Spearhead projects to harmonize and optimize quality processes, collaborating with global QA leaders to evolve the Quality Management System (QMS).
Profile
We are looking for a seasoned leader who balances technical mastery with a strategic, value-driven mindset.
* Educational Background: Advanced degree (BSc/MSc or equivalent) in Biology, Pharmaceutical Sciences, or a related field.
* Regulatory Expertise: Deep knowledge of ISO 13485, QMSR / 21CFR820, MDSAP, and IVDD/R, specifically within the In-Vitro Diagnostics (IVD) sector.
* Industry Experience: At least 10 years in Quality Assurance within the medical device or healthcare industry, including hands-on IVD experience.
* Proven Leadership: Minimum of 8 years in a managerial role with a track record of developing high-performing, results-oriented teams.
* Soft Skills: Exceptional interpersonal, negotiation, and communication skills, with the ability to turn quality activities into strategic organizational value.
* Process Improvement: Experience in Lean or Six Sigma; a Green Belt certification is highly desirable.
* Project Management: Solid background in managing complex quality projects and meeting deadlines in dynamic environments.
* Language Proficiency: Fluency in French and English is required; a good command of German is considered a significant asset.