QA Manager, GCP
Sobi - Swedish Orphan Biovitrum AB (publ)
full-time
Posted on:
Location Type: Remote
Location: Qatar
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Salary
💰 $112,000 - $153,000 per year
Tech Stack
About the role
- 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
- Support the collection of the data needed for Audit program risk assessment
- 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
- Assess and approve from quality perspective the GCP deviations (global and local, as applicable), GCP related CAPAs.
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.
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
GCPGCLPGPPQuality AssuranceAudit ManagementCAPAQA SystemsClinical TrialsICH GuidelinesRegulatory Requirements
Soft Skills
Quality OversightGuidanceSupportAssessmentApproval
Certifications
University Degree in Life Sciences