Complaint Quality Lead
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Are you looking for a strategic opportunity to transform global quality governance? As a Complaint Quality Lead, you drive the corporate complaint management process and ensure regulatory compliance for biopharmaceutical products. You serve as the primary expert contact for global teams and external partners.
Key responsibilities :
- You serve as the Complaint Quality Lead and corporate process owner for GMP complaint management, defining global procedural requirements.
- You foster an active network of entity process owners to share best practices, provide expert guidance, and nurture a continuous feedback culture.
- You collaborate with the QMS lead to plan and execute process changes across the organization to guarantee smooth transitions.
- You build a robust governance model for continuous process improvement and performance tracking using key metrics.
- You oversee the outsourced central complaint unit, ensuring full alignment with complaint programs and complete staff training.
- You manage service provider performance, including deviation resolution, CAPA implementation, and audit observation follow-ups.
- You monitor service level metrics, identify improvement areas, and lead the joint steering committee with our external partner.
- You generate product complaint trending reports for quality committees and deliver strategic visibility to senior management.
- You drive the integration and optimization of complaint workflows within our eQMS Veeva Source platform as the primary super user.
- You support initial complaint data intake coordination through to final market complaint closure.
- You maintain full inspection readiness for procedural documentation and actively participate in regulatory audits.
Qualifications :
- You hold a master's degree in life sciences, pharmacy, or engineering.
- You demonstrate proven leadership experience, ideally managing cross-functional teams of 10 to 15 people.
- You bring profound expertise in drug substance or drug product manufacturing within the biopharma industry.
- You possess expert knowledge of global GMP regulations, quality principles, and combination product QMS requirements.
- You display strong analytical capabilities, proficiency in excel data analysis, and a creative problem-solving mindset.
- You communicate with impact in English, while proficiency in French is a distinct advantage.
Benefits :
- You join a strategic global role with high visibility within a leading biopharmaceutical company.
- You enjoy a flexible hybrid work environment designed to support your professional growth and well-being.
- You receive an attractive salary package with comprehensive extra-legal benefits.
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