Responsable Qualité ESO / ESO Quality Americas Leader

Job description

Avec un héritage unique en dermatologie ainsi que des décennies d'innovation de pointe, Galderma est le leader émergent de sa catégorie dédié entièrement à la dermatologie, présent dans environ 90 pays. Nous proposons un portefeuille innovant, basé sur la science, de marques phares haut de gamme et de services qui couvrent l'ensemble du spectre du marché de la dermatologie en pleine croissance grâce à l'esthétique injectable, les soins dermo-cosmétiques et la dermatologie thérapeutique. Depuis notre création en 1981, nous avons consacré notre attention et notre passion à l'organe le plus grand du corps humain - la peau - en répondant aux besoins individuels des consommateurs et des patients avec des résultats supérieurs, en partenariat avec les professionnels de la santé. Parce que nous savons que notre peau façonne l'histoire de notre vie, nous faisons progresser la dermatologie pour chaque histoire de peau. Nous recherchons des personnes qui se concentrent sur l'obtention de résultats, ont envie d'apprendre et apportent une énergie positive. Ils doivent allier initiative, esprit d'équipe et de collaboration. Avant tout, ils doivent être passionnés par l'accomplissement de quelque chose de significatif pour les consommateurs, les patients et les professionnels de la santé que nous servons chaque jour. Nous visons à responsabiliser chaque employé et à favoriser leur développement personnel tout en veillant à ce que les besoins de l'entreprise soient satisfaits maintenant et à l'avenir. Dans notre entreprise, nous encourageons la diversité et respectons la dignité, la vie privée et les droits personnels de chaque employé. Chez Galderma, nous donnons activement à nos équipes des raisons de croire en notre ambition affirmée de devenir la première entreprise de dermatologie au monde. Avec nous, vous avez l'opportunité exceptionnelle d'acquérir de nouvelles expériences professionnelles enrichissantes et de créer un impact direct et sans précédent. has context menu The ESO SRT Quality Lead ensures that all sterile Galderma products produced by Contract Manufacturing Organizations (CMOs) meet the highest quality standards and comply with relevant government regulations. This includes adherence to cGMP, GDP, ISO, ICH, and other applicable regulations and guidance. The role leverages regulatory, industry, and technical expertise to oversee quality at CMOs, support company markets and distributors, and ensure compliance during product development and manufacturing. Products in scope are: semi-solid (majority) and oral products, with drug product status (pharmaceutical/OTC) and cosmetic product status (majority), including products manufactured by Galderma entities and/or subcontracted to external suppliers/partners. He/she Initiates continuous improvements actions and develop business excellence approach across Galderma Manufacturing sites or external partner. Main accountabilities External supplier (ESO/CMO) quality management Act as the primary QA contact for external suppliers and provide ongoing quality support. Lead the approval and renewal of Technical Quality Agreements. Lead and coordinate Quality Management reviews of external suppliers, defining performance and regulatory compliance-related goals, objectives, and KPIs. Support investigations, trends, complaints, CAPA, validation support, product release related issues; new product launches/technical transfer to external suppliers. Resolve critical/major quality issues and discrepancies found through audits, inspections, or complaints and their related investigations, and notify management of significant issues that may impact product quality or regulatory compliance or business continuity Regulatory and compliance oversight Ensure alignment with ICH guidelines and other applicable referential (examples listed: ICH Q1, Q3, Q8–Q14, FDA, EU, ISO) and data integrity expectations. Ensure compliance with GMP/GDP activities related to medicinal products according to EU-GMP and other guidelines, and ensure the team is compliant with all applicable regulations. Provide technical support to comply with local regulatory requirements and support industrial transfers (production and analytical), particularly for routine products. Regulatory documentation and inspection readiness Review and approve (if applicable) regulatory documents (CMC sections for pharmaceutical products, PIF for cosmetic products) and associated documentation (INDs, CTAs, IMPDs, BLAs, technical files, etc.). Support inspection readiness for launches and PAI, and oversee major/critical quality issues arising from audits, inspections, or complaints. Critical skills/competencies Technical knowledge: In-depth knowledge of cGMP, GDP, ISO, ICH, and other relevant regulatory requirements for sterile products. Strong Communication and interpersonal skills Problem-solving skills Analytical skills Ability to manage multiple projects and priorities simultaneously Leadership skills Ability to work in a global and complex environment Required education/experience Bachelor’s degree in Biology, Biotechnology, Biochemistry, Chemistry, Engineering, Microbiology or another relevant scientific or engineering discipline. 8+ years proven experience in Quality in the pharmaceutical/biopharmaceutical/cosmetic/medical care industry; with at least 5 years supporting worldwide semi-solid production/development (per product scope). Experience working with CMOs/external suppliers is highly preferred; experience in global lifecycle management and external partner oversight is highly preferred. Certification in quality management (e.g., ASQ Certified Quality Auditor) is a plus; Six Sigma / Lean Manufacturing certification valuable. Experience managing remote teams valuable.