Associate Director, Quality
SonoThera•South San Francisco, CA
•$80 - $93•Hybrid
About The Position
The Associate Director of Quality is responsible for managing quality assurance activities, providing strategic oversight of the implementation of a Quality Management System (QMS), and ensuring compliance with FDA, ICH, and other regulatory standards. This individual ensures compliance with GxP regulations (GLP, GMP, GCP as applicable) across our CROs. The successful candidate will establish quality frameworks from the ground up and lead quality initiatives that support the company's pipeline from preclinical research through clinical development in a fast-paced, resource-conscious environment.
Requirements
- Deep understanding of FDA, EMA, & ICH regulatory requirements
- Extensive knowledge of GMP, GLP, and GCP principles
- Experience with quality management systems and quality metrics
- Strong understanding of gene therapy development processes
- Experience with quality auditing and inspection processes
- Bachelor’s degree in life sciences or related field required
- 10 + years of biotech industry experience
- Minimum 3-5 years of experience managing CROs and vendor relationships
Nice To Haves
- Previous startup or small company experience highly preferred
- Experience building quality processes in early-stage development and understanding a fit-for-purpose approach
Responsibilities
- Develop, implement, and maintain quality systems and procedures to ensure compliance with applicable regulations (GLP, GMP, GCP )
- Implement pragmatic quality approaches that balance compliance with operational efficiency
- Create quality culture and awareness across all organizational levels
- Serve as the co-primary quality liaison for CDMO partnerships, overseeing quality agreements, audits, and ongoing compliance activities.
- Implement risk-based CRO oversight programs optimized for resource efficiency
- Build strong working relationships with CRO quality teams to ensure seamless collaboration
- Manage CRO performance with emphasis on speed, quality, and value delivery
- Ensure proper documentation and record-keeping practices
- Lead development of standard operating procedures (SOPs) and work instructions
- Maintain document control and change management processes
- Review key quality documentation, including protocols, reports, SOPs, batch records, and laboratory data.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
