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risk management vendor management cgmp vendor qualification regulatory inspections📋 Description
- Lead vendor qualification and lifecycle management for CMOs and suppliers.
- Define vendor risk classification criteria and oversight frequency.
- Oversee vendor assessments and approval processes.
- Monitor vendor performance with quality metrics.
- Lead vendor transitions or discontinuations as needed.
- Develop and maintain Quality Agreements aligned with contracts.
🎯 Requirements
- Bachelor’s degree in scientific discipline or equivalent.
- 12+ years pharma/biotech quality with vendor oversight.
- Strong knowledge of cGMP and global regulatory expectations.
- Experience managing vendor audit programs.
- Experience drafting and negotiating Quality Agreements.
- Experience supporting regulatory inspections.
🎁 Benefits
- Market leading compensation.
- 401K with employer match on first 3% and 50% on next 2%.
- Employee stock purchase program.
- Hybrid work model with flexible PTO.
- Comprehensive health care for employees and dependents.
- Paid parental leave and mental health support.
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