Backed by Canaan Partners.
About the role
Tyra Biosciences, Inc. is seeking an experienced and highly motivated Senior Director, GMP Quality Assurance to make impactful contributions to oncology and rare disease drug discovery projects targeting disease areas with high unmet medical need. The successful candidate will be a hands-on quality leader who thrives in a dynamic, cross-functional, and fully outsourced sponsor environment. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- Bachelor’s Degree in Chemistry, Biochemistry, Pharmacy, Chemical Engineering, or a related discipline and 15+ years of pharmaceutical GMP Quality Assurance experience, including 8+ years in a people leadership role
- Extensive experience overseeing outsourced small molecule drug substance and solid oral dose drug product manufacturing through CDMOs in a sponsor company environment
- Demonstrated experience supporting late-stage programs through NDA submission, including PPQ campaigns and FDA Pre-Approval Inspections
- Comprehensive knowledge of 21 CFR Parts 11, 210, and 211, EU GMP, ICH Q7–Q10 and Q12, and Good Distribution Practices
- Experience hosting regulatory inspections, conducting supplier audits, and negotiating Quality Agreements
More about this role
Tyra Biosciences, Inc. is seeking an experienced and highly motivated Senior Director, GMP Quality Assurance to make impactful contributions to oncology and rare disease drug discovery projects targeting disease areas with high unmet medical need. The successful candidate will be a hands-on quality leader who thrives in a dynamic, cross-functional, and fully outsourced sponsor environment.
The Senior Director is accountable for quality oversight of all externally manufactured drug substance and solid oral dose drug product, from regulatory starting materials through release and distribution. This role will build and lead the GMP QA function, own batch disposition, and drive inspection readiness as Tyra advances toward NDA submissions and commercial readiness.
Develop and execute the GMP Quality Assurance strategy in alignment with the Global Quality vision and company objectives for clinical supply, NDA submissions, and commercial launch.
Build and lead a high-performing GMP QA team, scaling internal and outsourced resources in a phase-appropriate manner, and manage the GMP QA budget.
Serve as the GMP Quality representative on CMC, Supply Chain, and program teams, providing...
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