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Entry LevelFull-timeGCP
Salary Range
$25,500 - $34,500 /year
This salary is estimated based on similar roles. The actual salary may vary.
About the Role
The QA Manager, GCP is responsible for ensuring quality oversight and quality assurance activities related to GCP/GCLP area within Sobi. This role involves guiding and supporting quality perspectives for GCP/GCLP and GPP related activities, including audits, inspections, and support of risk assessment for BLA/NDA/IND/CTA submissions.
Key Responsibilities
- →Ensure 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 risk assessment of the BLA/NDA/IND/CTA submissions
- →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 in GCP regulated area per Sobi procedures
- →Work with relevant stakeholders across the Sobi organization
- →Ensure GCP Audits management excellence of the end to end audit management process
- →Assess and approve from quality perspective the GCP deviations and GCP related CAPAs
- →Prepare regular status reports on performed audits, audit trending, deviation trending, CAPAs trending and agreed upon metrics
- →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
- →QA representative during GCP inspections global and site level, as applicable
- →Authoring GCP QA related processes, review and give guidance under global umbrella.
Requirements
- ✓Experience in quality assurance and GCP regulations
- ✓Strong understanding of audit management processes
- ✓Knowledge of regulatory submissions (BLA/NDA/IND/CTA)
- ✓Ability to work with cross-functional teams and stakeholders
- ✓Experience with GxP and Quality requirements
- ✓Proficiency in authoring and reviewing processes
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About Sobi
Sobi is a global specialty biopharmaceutical company focused on developing and delivering innovative therapies for patients with rare and severe diseases. Headquartered in Sweden, the company has established a strong presence in the life sciences industry, leveraging its expertise to address unmet medical needs. Founded with a commitment to improving patient outcomes, Sobi has grown into a leader in the rare disease sector, operating across multiple countries to bring life-changing treatments to those who need them most. Sobi’s main products and services include the development, manufacturing, and commercialization of specialty medicines, with a particular emphasis on hematology, immunology, and rare diseases. The company’s portfolio features therapies that target conditions such as hemophilia, immunoglobulin deficiencies, and inherited metabolic disorders. Key features of Sobi’s offerings include advanced treatment options, personalized care approaches, and robust patient support programs. The company primarily serves patients, healthcare providers, and institutions, focusing on communities affected by rare and complex conditions. Notable achievements include the successful launch of several breakthrough therapies and strategic acquisitions that have expanded Sobi’s capabilities and market reach. The company is recognized for its innovative research and patient-centric approach, positioning it as a trusted partner in the rare disease community. Sobi’s unique value proposition lies in its dedication to rare diseases, combining scientific excellence with a deep understanding of patient and caregiver needs to deliver meaningful treatments.
