rare strength
External Quality Operation Manager – GMP
Location
California
Posted
112 days ago
Salary
$130K - $153K / year
Seniority
Senior
Job Description
External Quality Operation Manager – GMP
Sobi - Swedish Orphan Biovitrum AB (publ)
• 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
Job 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
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