Quality Operation Manager – GMP

🕒 Março 4

🏄 California – Remoto

🏄 California – Remote

💵 $112.000 - $150.000 / 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

• Supporting transition from legacy paper-based processes to a scalable and compliant Electronic Quality Management System (eQMS) • Ensuring Quality System supports all stages of drug development — from nonclinical development through clinical development, regulatory submission (IND, NDA/BLA), commercialization, and product lifecycle management • Ensuring compliance with applicable GxP requirements (GLP, GCP, GMP), applicable FDA and global regulatory expectations, and industry best practices • Supporting inspection readiness, regulatory submissions, vendor oversight, and fostering a culture of quality and compliance across the organization

🎯 Requisitos

• Bachelor's degree (BS) or higher in a scientific discipline (e.g., Biology, Chemistry, Pharmacy, Biomedical Sciences, or related field) • Direct experience of transitioning from paper-based systems to an Electronic Quality Management System (eQMS) • Familiarity with IND and NDA/BLA regulatory submissions • Regulatory agency inspections and inspection readiness • GxP environments (GLP, GCP, GMP) • Several years of progressive Quality experience in the pharmaceutical or biotechnology industry • Demonstrated experience supporting multiple stages of drug development: research, clinical development, regulatory submission, commercialization, and lifecycle management • Working knowledge of applicable regulations including 21 CFR Parts 210, 211, 312, 820 (if applicable), ICH guidelines, and related global standard • Experience with validating eQMS platforms and computerized system validation (CSV/CSA) is a plus.

🏖️ 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