External Quality Operation Manager – GMP
Sobi - Swedish Orphan Biovitrum AB (publ)
full-time
Posted on:
Location Type: Remote
Location: California • United States
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Salary
💰 $130,000 - $153,000 per year
About the role
- Join Sobi’s mission to improve the lives of people with rare diseases by ensuring the highest standards of product quality and patient safety
- Act as the primary point of contact for external manufacturing partners
- Ensure compliance with GMP/GDP requirements
- Support release products to Markets
- Guide defining & monitoring remediation plans to address quality issues
- Ensure a good collaboration is maintained within the Global Quality Operations and cross-functionally
Requirements
- High level education (university degree or similar) within relevant area such as pharmaceutical, biotech or life science
- More than 5 years of experience within pharmaceutical, biotech product
- Experience in QA operation, production or other relevant area (GMP, GDP)
- More than 1 years of managing external quality oversight of CMOs
- Curriculum is requested for evaluating the batch release qualification requirement
- Fluently spoken and written English
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
- Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
GMPGDPQA operationsproduct releaseremediation plansbatch release qualification
Soft Skills
collaborationcommunication