Associate Director of Quality, Devices & Biologics
An established and innovative biopharma company is seeking an AD / Director-level of Quality with expertise in Devices and Biologics. This oncology company has rapidly grown from start-up to market-phase, and they're looking to impact the industry by commercializing 4 more products in the coming years.
The Associate Director of Quality, Devices & Biologics will have the following responsibilities:
- Provide engineering / device counsel across cross-functional departments
- Support all precommercial products which have a combination device component (auto-injectors, pre-filled syringes)
- Effectively present and communicate findings to senior leadership
- Implement and oversee all aspects of design control for precommercial products
- Assist in conducting investigations for any non-conformance in precommercial product lines
The ideal candidate will have the following skill set:
- Ideally 10+ years of experience in quality engineering
- Combination Product experience
- Product Development and design control
- Strong oral communication skills
