Experteer Overview In this role you ensure quality across external manufacturing sites, overseeing GMP-compliant production, testing, packaging, storage, and distribution. You provide expert QA guidance to site leadership, uphold robust quality systems, and coordinate regulatory readiness and inspections. You will lead or mentor QA professionals, drive continuous improvement, and manage metrics and investigations. This position offers the opportunity to shape external quality oversight for a global healthcare company focused on women’s health and biosimilars. You will work cross-functionally to enable compliant, high-quality products at external facilities.Compensaciones / Ventajas
- Lead and develop a QA team (where applicable), including regular 1-on-1s and development planning
- Oversee quality systems, data, and processes for external manufacturing and release activities
- Manage budget planning and cost control for EQA activities




- Ensure compliance with GMP and regulatory requirements across domestic and foreign sites
- Monitor metrics, identify trends, and drive root-cause analysis for process improvements
- Oversee batch documentation review, deviation investigations, and product release oversight at EE
- Support regulatory inspections, audits, and change control processes; ensure audit readiness
- Foster continuous improvement and build robust quality systems at the external entityResponsabilidades
- Minimum 5 years’ experience in pharmaceutical/biotech QA/QC with knowledge of GMP/regulatory requirements
- Strong interpersonal, communication, coaching, and leadership skills
- Ability to collaborate across boundaries and influence site leadership
- Proficiency in English (spoken and written)
- Experience with regulatory inspections and significant investigations is preferredRequisitos principales
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📌 External Quality, Associate Director (Madrid)
🏢 Organon u0026
📍 Madrid