Sonothera
Associate Director, Quality
South San Francisco · Director · Part-time
Sponsorship not specified$80k-$93kDetected 5 days ago
GCPAuditingGMPFDA RegulatoryCRISPRResearchAnimal StudiesLeadershipCommunicationCollaborationGxP
About the role
- 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.
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
- 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
- Lead development of standard operating procedures (SOPs) and work instructions
- Maintain document control and change management processes
Requirements
- Experience building quality processes in early-stage development and understanding a fit-for-purpose approach
Skills
- 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
- Previous startup or small company experience highly preferred
- Minimum 3-5 years of experience managing CROs and vendor relationships
- Technical Skills
- Temporary 6 months, with possibility of 6-month extension
- This individual ensures compliance with GxP regulations (GLP, GMP, GCP as applicable) across our CROs.
Compensation
- The salary range for this temporary position is $80.00 to $93.00 USD per hour.
- This salary range is an estimate, and the actual salary may vary based on various factors, including, without limitation, individual education, experience, tenure, skills, and abilities, as well as internal equity and alignment with market data, including potential adjustments for geographic location.
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This listing is sourced directly from Sonothera's careers page and normalized into a canonical job model.