Associate Director, Quality & GxP Compliance

SonoThera; South San Francisco (CA); Hybrid; USD 190,000 - 220,000; Full time

Benefits offered by this job

Salary range: $190,000–$220,000 USD

Job summary

SonoThera is seeking an Associate Director of Quality in the San Francisco Bay Area to lead the design and implementation of a robust QMS, ensuring GLP, GMP, and GCP compliance across CROs. This senior role reports to the VP, Head of Regulatory and Quality in a fast-paced biotech environment.

The ideal candidate has 10+ years in biotech, deep FDA/ICH knowledge, and proven CRO management experience, including building quality processes in early-stage development.

Qualifications

• Bachelor’s degree in life sciences or related field.
• 10+ years of biotech industry experience.
• Experience managing CROs and vendor relationships (3–5 years preferred).
• Startup or small company experience highly preferred.

Responsibilities

• Develop, implement, and oversee QMS and quality procedures in compliance with GLP, GMP, GCP.
• Lead CRO oversight and audits to ensure speed, quality, and value delivery.
• Maintain document control, change management, and SOP development.
• Review critical quality documents including protocols, reports, and batch records.
• Build quality culture and drive cross-functional collaboration across functions.

Skills

Quality systems

GxP compliance

FDA/ICH knowledge

CRO management

Education

Bachelor’s degree in life sciences

Job description

SonoThera is seeking an Associate Director of Quality in the San Francisco Bay Area to lead the design and implementation of a robust QMS, ensuring GLP, GMP, and GCP compliance across CROs. This senior role reports to the VP, Head of Regulatory and Quality in a fast-paced biotech environment.

The ideal candidate has 10+ years in biotech, deep FDA/ICH knowledge, and proven CRO management experience, including building quality processes in early-stage development.