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Salary: USD 190,000 - 220,000 / annual
SonoThera is seeking an Associate Director of Quality to lead quality assurance and regulatory compliance activities for a gene therapy company. This role reports to the VP, Head of Regulatory and Quality, and is responsible for building and managing quality systems from the ground up in a fast-paced, resource-conscious environment.
Key Responsibilities:
Quality Program Development: Develop, implement, and maintain quality systems and procedures ensuring compliance with GLP, GMP, and GCP regulations. Create pragmatic quality approaches that balance regulatory compliance with operational efficiency. Foster quality culture and awareness across all organizational levels.
CRO Management & Strategic Partnerships: Serve as co-primary quality liaison for CDMO partnerships, overseeing quality agreements, audits, and ongoing compliance. Implement risk-based CRO oversight programs optimized for resource efficiency. Build strong working relationships with CRO quality teams and manage vendor performance with emphasis on speed, quality, and value delivery.
Quality Systems & Documentation: Develop and maintain quality systems, procedures, and documentation 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.
Technical Skills Required:
- Deep understanding of FDA, EMA, and 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
- Excellent leadership, communication, and interpersonal skills
Qualifications:
- 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
- Previous startup or small company experience (highly preferred)
- Experience building quality processes in early-stage development and understanding fit-for-purpose approaches
