Quality Operation Manager – GMP

🕒 March 4

🏄 California – Remote

🏄 California – Remote

💵 $112k - $150k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

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Sobi - Swedish Orphan Biovitrum AB (publ)

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1991

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Sobi - Swedish Orphan Biovitrum AB (publ) is a global leader in providing innovative treatments for people with rare diseases. Specializing in therapeutic areas such as haematology and immunology, Sobi is committed to improving patient access to medicines for rare and debilitating conditions. With a strong R&D pipeline, the company is actively pursuing new therapies and collaborating globally to transform patient care in areas such as haemophilia and immune thrombocytopenia. Sobi also engages in extensive sustainability and humanitarian aid programs, demonstrating a firm commitment to patient-centric care and societal contributions.

📋 Description

• 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

🎯 Requirements

• 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.

🏖️ Benefits

• 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