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Summary: As an ESO QA Manager, you will oversee supplier quality system compliance to mitigate risks related to product/API quality and reduce costs. Highlights: 1. Oversight of supplier quality system compliance 2. Support External Suppliers Qualification process 3. Contribute to process simplification and QMS improvements Sandoz is a global market leader in Biosimilar and Generics medicine, a market leader in a sector is helped pioneer. Our Vision is to be the world’s leading and most valued generic and biosimilar medicine company. **We are pursuing access to medicine goals in two areas:** * ensuring responsible access to critical antibiotics which is seen as the backbone of modern medicine, and * democratizing access to biologic therapies through healthy competition AsESO QA Manager, you will be responsible for the oversight of the supplier quality system compliance to mitigate risks related to product/API quality and to reduce costs associated to poor product quality, pursuant to the law, internal regulations, good practices and business objectives **Your key responsibilities will include:** * Support External Suppliers Qualification process. * Negotiation of Quality Assurance Agreements (QAA) with external partners . * Change and deviation management, complaint handling. * Escalate risks and issues, as well as propose mitigating actions. * Responsibility for ensuring timely achievement of project Quality deliverables. * Contribute to process simplification and QMS improvements * Stability reports and PQR’s review and approval. **Key performance indicators:** * The number and severity of cGMP issues identified during internal Global Quality Organization and Health Authority audits of External Supplier * Compliance of products according to agreed specification * No out of stock incidents related to QA activities * Training plans are met within the team * KPIs as identified in the quality target letter **What you will bring to the role:** * University degree in Microbiology, Biotechnology, Biochemistry or equivalent. * Minimum 5 years of working experience in Pharmaceutical/Biopharmaceutical/API products. quality/quality assurance or operations. * Excellent communication and organizational skills. * Excellent skills in identifying issues and solving problems. * Excellent\& detailed knowledge of GMP\-regulations (EMA; FDA, CA, etc). * Fluent in English. * Knowledge of Microsoft Office. * Fluent in speaking/ writing in English. Why Sandoz? Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more! With investments in new development capabilities, state\-of\-the\-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low\-cost, high\-quality medicines, sustainably. Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible\-hybrid careers, where diversity is welcomed and where personal growth is encouraged! The future is ours to shape! **Commitment to Diversity\& Inclusion:** Sandoz is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
