Similar Jobs
See allAssociate Director, Clinical Quality Lead
Osanni Bio
US
GCP
SOP Development
Regulatory Compliance
Vice President, Quality
Syner-G
US
GxP
Business Development
Leadership
Vice President, Global Supply Chain
Kailera Therapeutics
US
Supply Chain Management
S&OP
ERP Systems
Director, Quality Systems
Partner Company
US
Data Integrity
Supplier Quality Engineer
Intuitive Surgical
US
ISO 13485
Project Management
Role Overview:
- Lead quality for infigratinib and serve as Responsible Person for wholesale distribution.
- Manage quality team and QMS, oversee contract service providers, and inspect readiness.
Responsibilities:
- Serve as named RP on WDA for GDP compliance.
- Lead quality team development and inspection readiness.
Qualifications:
- BS/MS degree with GDP/GMP training and 10+ years experience.
- Prior RP experience and leading EU regulatory inspections.
- Strong leadership and analytical skills.
BridgeBio
BridgeBio is a biotech company pioneering a pooled project model to accelerate early-stage research for rare diseases. The company fosters a collaborative culture with small expert teams, encouraging curiosity and experimentation.