QA Manager, GCP

🔥 12 minutes ago

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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

• Ensuring quality oversight and quality assurance and quality by design activities related to GCP/GCLP area • Guide and support from a quality perspective the GCP/GCLP and GPP related activities within Sobi, including audits, inspection and support of and risk assessment of the BLA/NDA/IND/CTA submissions under global umbrella. • Support the collection of the data needed for Audit program risk assessment • Support from quality perspective the clinical studies related activities across Sobi • Ensure qualification of global and local ESP, as applicable, in GCP regulated area per Sobi procedures • Ensure GCP Audits management excellence of the end to end audit management process and overview of the assigned audits, as planned • Assess and approve from quality perspective the GCP deviations (global and local, as applicable), GCP related CAPAs. • Prepare regular status report on performed audits, audit trending, deviation trending, CAPAs trending and agreed upon metrics to ensure Quality oversight. • Contribute and support the GCP audit risk assessment according to SOPs. • Ensure active contribution in the cross-functional team with procurement, business owners for GxP and Quality requirements and documented qualification of GCP service providers and review provisions in contracts/Quality agreements, as applicable. • QA representative during GCP inspections global and site level, as applicable and contribute to the Inspection Readiness framework and promote continuously quality mindset across Sobi. • Authoring GCP QA related processes, review and give guidance under global umbrella.

🎯 Requirements

• University degree or similar in Life Sciences or related discipline. • At least 5 years experience from the pharmaceutical industry in Clinical Quality Assurance or in the operational conduct of clinical trials and the application of GCP audit and/or Quality Assurance experience. • Excellent knowhow of the applicable ICH GCP guidelines, industry best practices and FDA, EMA and ROW regulatory requirements. • Documented education/experience in QA systems and preferably auditing. • Structured with focus on results and detail oriented. • Strong interpersonal skills with communicative and flexible attitude. • Proactive and collaborative mindset. • Strong multi-tasking abilities with high resilience at stress and adaptative skills.

🏖️ 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