External Quality Operation Manager – GMP

🕒 Março 3

🌲 North Carolina – Remoto

🌲 North Carolina – Remote

💵 $130.000 - $153.000 / ano

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

👔 Gerente

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Sobi - Swedish Orphan Biovitrum AB (publ)

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

Fundada em 1991

🧬 Biotecnologia

💊 Farmacêutico

⚕️ Seguro de Saúde

Biotechnology • Pharmaceuticals • Healthcare Insurance

A Sobi é uma empresa biofarmacêutica internacional especializada em transformar a vida de pessoas com doenças raras. Oferecemos acesso sustentável a terapias inovadoras nas áreas de hematologia, imunologia e indicações especiais. Atualmente, empregamos aproximadamente 1.600 pessoas na Europa, América do Norte, Oriente Médio e Ásia. Em 2021, nosso faturamento foi de SEK 15,5 bilhões. As ações da Sobi (STO:SOBI) estão listadas na Nasdaq de Estocolmo. Você pode encontrar mais informações sobre a Sobi em sobi.com. Leia nossa política de mídias sociais em https://www.sobi.com/en/social-media-policy Você pode saber mais sobre a Sobi em https://www.youtube.com/c/sobipharma

Descrição

• Perform as EQOM to act as Single point of contact for all quality related activities at the Contract Manufacturing Organization (CMO) • Ensure that all aspects of handling, manufacturing, distribution of products are in compliance with Sobi Quality system, the effective Quality Technical Agreement (QTA), that they meet relevant CGMP regulatory requirement • Support release products to Markets • Support the External Service Provider (CMO) Qualification • Ensure Quality Technical Agreement (QTA) be established appropriately and ensure valid QTA clearly defines roles & responsibilities between Sobi and the External Supplier • Ensure implementation and maintaining Quality Risk Assessment and KPIs on Quality External activities • Guide defining & monitoring remediation plans to ensure that issues are suitably addressed • Drive or support improvement opportunities for processes and product Quality performance • Ensure CMO provides product reviews or data (APQR/PQRs, stability reports) as specified in the QTA • Assess the performance of the product and the process as per Sobi requirement • Manage/approve quality issues (deviations, CAPA and complaints) as per QTA and Sobi requirement • Ensure that Change requests either from CMO or from Sobi are managed according to the QTA and Sobi requirements • Support that Quality Audits of the CMO are performed according to Sobi requirement and the QTA • Lead to define strategy of implementation and monitoring of key Quality transformation initiatives and align with all process stakeholders outside of Quality organization • Lead or act as Quality representative in projects related to CMO eg Tech Transfer, Launch • Assess and ensure CMO for Health Authorities (HAs) inspection readiness • Support HA inspections/audits of Sobi • Responsible to inform the line manager and cross functional teams of all critical & major issues and escalate any issues as per Sobi escalation policy • Ensure a good collaboration is maintained within the Global Quality Operations and cross-functionally • Ensure the batch release as required

🎯 Requisitos

• High level education (university degree or similar) within relevant area such as pharmaceutical, biotech or life science • More than 5 years of experience within pharmaceutical, biotech product • Experience in QA operation, production or other relevant area (GMP, GDP) • More than 1 years of managing external quality oversight of CMOs • Curriculum is requested for evaluating the batch release qualification requirement • Fluently spoken and written English

🏖️ Benefícios

• Competitive compensation for your work • Generous time off policy • Opportunity to broaden your horizons by attending popular conferences • Emphasis on work/life balance • Collaborative and team-oriented environment