Senior Manager, GMP and QMS Quality Operations
Karyopharm TherapeuticsUnited States
Posted February 24, 2024
150000 - 175000 USD
Full Time
About the Company
Karyopharm is a biopharmaceutical company focused on developing innovative therapies for cancer.
Job Description
The Senior Manager, GMP and QMS Quality Operations will provide strategic and operational support within GMP Quality and Quality Systems, leading training initiatives, providing vendors management support, driving process improvement, and partnering cross-functionally to support successful Quality operations.
Requirements
- Bachelor's degree in life science or related discipline
- 7-10 years of experience in QA, QMS, QC or Manufacturing in an FDA-regulated industry, preferably biologic therapeutics
- Direct experience with regulators (e.g., BLA, MAA submissions and/or inspections)
- Ability to lead improvement projects
- Excellent communication skills and a proven track record influencing/building/promoting a culture of Quality and Excellence
- Ability to apply critical thinking and problem-solving skills to decision making and operational priorities
Benefits
- Medical, dental, vision, 401(k), and more
- Equity
- Annual target bonuses
- Comprehensive benefits package
- Generous PTO and Holidays
- Wellness Program with a monthly stipend
- Cell phone allowance
