---
title: 'Associate Director, Quality at SonoThera'
canonical: 'https://feeny.ai/job/associate-director-quality-sonothera-south-san-francisco-53hc59gar7nx'
type: 'job'
last_seen: '2026-09-13'
---

# Associate Director, Quality at SonoThera

- **Company:** SonoThera
- **Location:** South San Francisco, CA
- **Posted:** 2025-08-07
- **Last confirmed live:** 2026-09-13
- **Apply:** https://sonothera.com/careers/?gh_jid=4591088006

## Job description

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. 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. The Associate Director, Quality reports to the Vice President, Head of Regulatory and Quality. This is a full-time hybrid role that is temporary for 6 months, with the possibility of a 6-month extension.

What You Will Do:

Quality Program Development

- 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
- Excellent leadership, communication, and interpersonal skills

CRO Management & Strategic Partnerships

- 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

Quality Systems & Documentation

- Develop, implement, and maintain quality systems and procedures to ensure compliance with applicable regulations (GLP, GMP, GCP.).
- 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.

Technical Requirements and Skills:

Technical 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

## Qualifications

- Bachelor’s degree in life sciences or related field required
- 10 + years of biotech industry experience
- Previous startup or small company experience highly preferred
- Experience building quality processes in early-stage development and understanding a fit-for-purpose approach
- Minimum 3-5 years of experience managing CROs and vendor relationships

Compensation: The salary range for this temporary position is $90.00 to $110.00 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.

## About SonoThera

## Company Overview
- **One-liner**: SonoThera is developing a proprietary, nonviral, ultrasound-mediated gene delivery platform (RIPPLE™) to enable safe, redosable, and targeted genetic medicines for a range of diseases.
- **Entity Type**: Private (Series B)
- **Headquarters**: South San Francisco, California, United States
- **Founded**: 2022 (public launch with Series A)
- **Founders**: Kenneth Greenberg, PhD (CEO & Co-Founder) and Steve Feinstein, MD (CSO & Co-Founder)

## Core Business
- **Primary industry**: Biotechnology – Genetic Medicines / Gene Therapy
- **Target customers**: B2B (pharma/biotech partnerships), clinical-stage drug developer; ultimately patients with genetic diseases
- **Mission**: To deliver the next generation of genetic medicines to treat the root cause of human diseases.

## Products & Services
- **RIPPLE™ Platform**: Proprietary, non-invasive, ultrasound-mediated delivery technology that enables broad, targeted biodistribution, delivery of diverse genetic payloads (DNA, RNA, siRNA, ASOs, gene editors) without size restriction, and is designed to be redosable, immune stealth, and cost-effective.
- **Therapeutic Pipeline**: Preclinical programs targeting:
  - Muscle: Duchenne Muscular Dystrophy (DMD), Limb-Girdle Muscular Dystrophies (LGMD)
  - Kidney: X-linked Alport Syndrome (x-LAS), Autosomal Dominant Polycystic Kidney Disease (ADPKD)
  - Discovery: Genetic diseases of the heart, adipose tissue, and brain (CNS)

## Market Standing
- **Valuation / Latest Financing**: Closed an oversubscribed **$125 million Series B** (date not specified but recent, likely 2025). Previously raised a **$60.75 million Series A** (December 2022, led by ARCH Venture Partners).
- **Total Funding to Date**: At least **$185.75 million** (Series A + Series B). Additional founding capital may exist but not fully detailed.
- **Notable Investors**: Series A led by **ARCH Venture Partners**; the Series B syndicate is described as top-tier venture capital and strategic investors (specific names not fully listed, but includes leading global ultrasound companies as partners).
- **Growth Signals**: 
  - Headcount grew **28.6% YoY** to **52 employees** (LinkedIn data).
  - Full vertical integration of payload development and in vivo pharmacology.
  - Strong intellectual property portfolio with foundational RIPPLE™ patents.
  - First human clinical trial planned for **2027**, with a steady cadence of INDs following.

## Competitive Advantages
- **Nonviral delivery**: Avoids immunogenicity and material-related toxicity of AAVs and LNPs.
- **Redosable**: Maintains stable therapeutic expression over time, overcoming a major limitation of viral vectors.
- **Unlimited payload size**: Can deliver large gene constructs (e.g., full-length dystrophin for DMD).
- **Targeted biodistribution**: Ultrasound profiles enable delivery to nearly any organ with minimal off-target effects.
- **Cost-effective CMC**: Simpler manufacturing compared to viral vectors.
- **Proven safety foundation**: Co-founder Dr. Feinstein invented the first two FDA-approved ultrasound microbubble agents (Albunex® and Optison®).

## Strategic Focus
- Advance the RIPPLE™ platform toward clinical proof-of-concept, beginning with **first-in-human trial in 2027**.
- Expand pipeline across multiple organ systems (muscle, kidney, liver, heart, CNS).
- Continue building in-house capabilities for payload design, engineering, and manufacturing.
- Attract strategic partnerships with leading ultrasound companies and biopharma.

## Why Work Here
- **Culture**: Values-driven environment emphasizing resilience, rigor, passion, open-mindedness, collaboration, and innovation. The company states “science is hard, but we are determined to persevere” and “we act with urgency because patients are waiting.”
- **Team & Environment**: Small but rapidly growing team (~50 people) offering high ownership and impact. Described as “a great place to do science” with top-quality peers.
- **Work Policy**: Not explicitly stated; likely lab-based roles in South San Francisco with potential for hybrid office/lab arrangements.
- **Perks & Highlights**: Opportunity to work on cutting-edge genetic medicine technology with a well-funded, well-backed startup; close collaboration across research, operations, and leadership.
- **Current Openings**: 3 active roles (Nucleic Acid Analytics Intern, Executive Assistant, Senior/Principal Scientist) as of the latest data.

## Sources
1. [SonoThera Website](https://sonothera.com)
2. [SonoThera Careers Page](https://sonothera.com/careers/)
3. [SonoThera About & History](https://sonothera.com/about-us/)
4. [SonoThera Science & Pipeline](https://sonothera.com/science/)
5. [SonoThera LinkedIn Profile](https://www.linkedin.com/company/sonothera)

## Other roles at SonoThera

- [Research Associate-II/Senior Research Associate, Histology](https://feeny.ai/job/research-associate-ii-senior-research-associate-histology-sonothera-south-san-4qsbtwmjm5w1) — South San Francisco, CA