Senior Director of Quality Assurance
4 weeks ago
We are seeking a highly experienced Senior Director of Quality Assurance to provide quality oversight of our clinical development programs and manufacturing. As a key member of our team, you will be responsible for ensuring the highest standards of quality and compliance in our GMP suppliers.
Key Responsibilities
* Provide quality support and guidance for our CMC programs
* Ensure that GMP quality documentation is securely archived and retrievable
* Investigate, evaluate, and manage potential quality impact of product complaints and temperature excursions
* Ensure inspection readiness at our GMP suppliers
* Provide GMP quality review and feedback on regulatory application submissions and agency responses/information requests
Requirements
* Bachelor's degree in a scientific field
* 10+ years' experience in GMP Quality or Manufacturing in a biotechnology or pharmaceutical setting
* Experience supporting early phase clinical through commercial manufacturing, including the use of contract manufacturers
* Ability to work in a fast-paced, ever-changing environment, prioritizing and managing multiple tasks simultaneously
What We Offer
* Approximately 10-20% travel (domestic and international)
* Opportunity to work with a publicly traded biotechnology company developing biologics to treat chronic dermatological diseases
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