Senior Manager, Quality Assurance
About The Position
At uniQure, we are delivering on the promise of gene therapy and delivering hope for patients facing urgent unmet medical needs. Every role in our organization carries profound purpose; whether you're in research, operations, access, or support, your contributions impact patients. We're seeking passionate professionals who thrive in high-stakes environments, uphold rigorous quality standards, and share our relentless commitment to transforming the lives of patients. Join us in making the impossible possible, where your expertise becomes a catalyst for life-changing treatments. uniQure is seeking a motivated, hands-on Senior Manager, Quality Assurance. This position will be instrumental in ensuring that external stakeholders comply with applicable GxP and regulatory requirements in support of the advancement of uniQure’s gene therapy pipeline. The ideal candidate has significant QA experience in managing external CMOs from clinical to commercial phase and relevant product launch success.
Requirements
- Minimum of a BA/BS degree in life sciences
- Minimum of 8 years working in pharma/biotech
- Experience with product disposition
- Strong collaboration skills to manage external stakeholders
- Commercial launch experience
- Excellent organizational skills and ability to prioritize in a fast-paced environment
Responsibilities
- Management of external quality operations in support of GMP manufacturing (clinical and commercial) activities
- Manage CDMO/CTO performance in accordance with established Quality Agreements
- Manage external deviations, OOS, and OOT investigations while adhering to cGMP principles and guidelines
- Review batch records, tech transfer reports, process validation reports
- Complete disposition of GMP batches
- Support commercial launch activities
- Drive continuous improvement to increase efficiency internally and externally by ensuring effective implementation of QMS processes, including deviations, CAPAs, change controls, and document control
- Lead establishment of supplier score cards for KPIs and routine quality performance assessments
- Assist in establishing a product complaints function
- Create and foster a culture of collaboration and engagement to advance quality outcomes and operational excellence
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What This Job Offers
Job Type
Full-time
Career Level
Senior
