---
title: 'Associate Director, GMP Quality at Formation Bio'
canonical: 'https://feeny.ai/job/associate-director-gmp-quality-formation-bio-boston-cmfdvxeszbkf'
type: 'job'
last_seen: '2026-09-12'
---

# Associate Director, GMP Quality at Formation Bio

- **Company:** Formation Bio
- **Location:** Boston, MA / New York, NY
- **Posted:** 2026-07-13
- **Last confirmed live:** 2026-09-12
- **Apply:** https://job-boards.greenhouse.io/formationbio/jobs/8043939

## Job description

## About Formation Bio

Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development.

Advancements in AI and drug discovery are creating more candidate drugs than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of new medicines that can reach patients, Formation Bio, founded in 2016 as TrialSpark Inc., has built technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to bring new medicines to patients. The company is backed by investors across pharma and tech, including a16z, Sequoia, Sanofi, Thrive Capital, John Doerr, Spark Capital, SV Angel Growth, and others.

You can read more at the following links:

- [Our Vision for AI in Pharma](https://www.formation.bio/blog/our-vision-for-ai-in-pharma)
- [Our Current Drug Portfolio](https://www.formation.bio/licensing-and-pipeline)
- [Our Technology & Platform](https://www.formation.bio/technology)

At Formation Bio, our values are the driving force behind our mission to revolutionize the pharma industry. Every team and individual at the company shares these same values, and every team and individual plays a key part in our mission to bring new treatments to patients faster and more efficiently.

## About the Position

The Associate Director, GMP Quality Assurance is responsible for ensuring that all GMP-regulated activities, including manufacturing, testing, packaging, labeling, storage, and distribution of Formation Bio's portfolio are executed in compliance with regulatory requirements, industry standards, and company procedures. This role supports CMC development activities, audits CDMOs, conducts batch release, and performs investigations. The ideal candidate is a hands-on quality leader with strong communication skills and the ability to pivot in a dynamic environment.  Additionally, the role explores opportunities to integrate artificial intelligence (AI) technologies to improve efficiency, compliance, and overall quality assurance practices.

## Responsibilities

- Ensure compliance with global regulations (e.g., FDA, EMA, ICH) and internal SOPs. Policies and Work Instructions
- Review and approve GMP documents, including SOPs, master batch records, specifications, protocols, and reports
- Perform QA review of executed batch records, supporting manufacturing documents, and testing results to support timely and compliant batch disposition
- Support investigations into deviations, OOS/OOT results, environmental monitoring excursions, and quality events
- Conduct internal audits to assess compliance and identify improvement opportunities
- Conduct the qualification and periodic assessment of suppliers, CDMOs, laboratories, and service providers
- Review and maintain Quality Agreements, ensuring external partners meet GMP expectations
- Support preparation for and participation in regulatory inspections and due diligence audits
- Apply risk management principles (e.g., FMEA) to guide decision-making
- Champion a culture of quality, transparency, and continuous improvement

## About You

- Bachelor’s degree in scientific discipline (e.g., Chemistry, Biology, Engineering, Pharmaceutical Sciences)
- Minimum of 10 years’ experience in pharmaceutical GMP Quality Assurance, with specific experience in biologics / large-molecule manufacturing and testing
- Deep understanding of GMP expectations (e.g., FDA, EMA, and ICH) and a commitment to patient safety
- Excellent communication, organization, and collaboration skills
- Ensures accuracy and completeness in documentation and decision-making
- Ability to lead investigations and write clear, concise supporting documents
- Experience with CMO oversight or virtual manufacturing models
- Thrive in a dynamic, fast-paced environment with evolving priorities

Total Compensation Range: $161,500 - $202,000 Compensation Individual compensation is determined by several factors, including role scope, geographic location, and skills & experience. Your offer will reflect where you fall within the range based on these considerations. In addition to base salary, we offer equity, comprehensive benefits, and generous perks. If the posted range doesn't match your expectations, we still encourage you to apply!

Where We Hire Formation Bio is prioritizing hiring in key hubs, primarily the New York City and Boston metro areas, with a hybrid model requiring 3 days per week in office. Applicants from the Research Triangle (NC) and San Francisco Bay Area may also be considered. Please apply only if you reside in these locations or are willing to relocate.

Equal Opportunity Formation Bio is committed to building a diverse and inclusive team. We are an equal opportunity employer and welcome candidates from all backgrounds. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, ancestry, sex (including pregnancy, childbirth, breastfeeding, and related medical conditions), gender identity or expression, sexual orientation, age, disability, genetic information, marital status, military or veteran status, or any other characteristic protected by federal, state, or local law.

## About Formation Bio

## Company Overview
- **One-liner**: Formation Bio is an AI-native, tech-driven pharmaceutical company that acquires and develops clinical-stage drug candidates faster and more efficiently using its proprietary technology platform.
- **Entity Type**: Private (Series D)
- **Headquarters**: New York, New York, USA
- **Founded**: Year not publicly specified; founded by Ben Liu and Linhao Zhang
- **Founders**: Ben Liu (CEO & Co-Founder) and Linhao Zhang (Co-Founder)

## Core Business
- **Primary industry**: Pharmaceuticals / Drug Development / AI in Biotech
- **Target customers**: B2B; partners include pharmaceutical companies, universities, and biotech firms that have clinical-stage assets; end customers are patients awaiting new treatments.
- **Mission or purpose statement**: "To bring new treatments to patients faster and more efficiently."

## Products & Services
- **AI-Native Drug Development Platform**: A proprietary, tech-driven platform that integrates patient intelligence, data surveillance, and a universal data layer to power hyper-efficient clinical development across the drug lifecycle.
- **Drug Asset Acquisition & Development**: Formation Bio acquires promising clinical-stage drug candidates from pharma, universities, and biotech, then develops them in-house using flexible financing pathways and bespoke exit strategies.
- **Clinical Operations**: In-house management of trials including patient recruitment, site management, and study monitoring.

## Market Standing
- **Valuation/Market Cap**: Not publicly disclosed (private company)
- **Total Funding**: Not publicly disclosed in search results; investors include Sequoia Capital, a16z (Andreessen Horowitz), Thrive Capital, Section 32, Sam Altman, Michael Moritz, John Doerr, and others.
- **Notable Investors/Partners**: Sequoia Capital, a16z, Thrive Capital, Section 32, Sam Altman, Michael Moritz, John Doerr; advisors include former Pfizer CSO Mikael Dolsten, former Allergan R&D head Lawrence Olanoff, and Microsoft EVP of CoreAI Jay Parikh.
- **Growth Signals**: The team and advisors have collectively worked on 45+ approved drugs; the company is actively hiring across multiple functions (engineering, data science, clinical operations, business development) in four key hubs; has attracted top-tier tech and pharma talent.

## Competitive Advantages
- **AI-Native Model**: Unlike traditional pharma, Formation Bio is built from first principles with AI and data-driven iteration at its core, creating feedback loops that accelerate decision-making.
- **In-House Execution**: Runs trials in-house (patient recruitment, site management, monitoring) rather than outsourcing, enabling tighter control and faster cycles.
- **Cross-Industry Talent**: Bridges the best of tech and pharma, combining software engineering, data science, and AI with deep drug development expertise.
- **Flexible Deal Structures**: Offers varied financing and exit pathways for drug programs, making it a preferred partner for asset holders.

## Strategic Focus
- **Radical Efficiency**: Ruthless process improvement across the drug development lifecycle without sacrificing quality or safety.
- **Platform Scaling**: Building a scalable, tech-driven pharma company that can handle multiple drug programs simultaneously.
- **Therapeutic Breadth**: Focusing on critical unmet patient needs across a variety of therapeutic areas.

## Why Work Here
- **Mission-Driven**: "The world’s hardest problems deserve the world’s best people" — employees work on transforming how medicines are created, with tangible patient impact.
- **Hybrid Culture**: Teams are hybrid based in four hubs: New York City, Boston, San Francisco Bay Area, and North Carolina’s Research Triangle.
- **Comprehensive Benefits**: Health, vision, dental insurance; 401k; pre-tax commuter benefits; short and long-term disability; life insurance.
- **Parental Leave**: 16 weeks paid for birthing parents, 12 weeks for non-birthing parents.
- **Flexible PTO**: Trust-based time off policy.
- **Professional Development**: Fireside chats with industry experts, conference passes, certification courses, internal mobility, manager training, leadership coaching.
- **Community**: Quarterly company gatherings, bi-annual company-wide retreat, Employee Resource Groups.
- **Engineering Culture**: AI-native, data-driven, first-principles thinking — a place for people who "chase excellence" and want to solve hard problems.

## Sources
1. [formation.bio](https://www.formation.bio/)
2. [formation.bio/about-us](https://www.formation.bio/about-us)
3. [formation.bio/careers](https://www.formation.bio/careers)
4. [formation.bio/our-model](https://www.formation.bio/our-model)
5. [Greenhouse job board](http://job-boards.greenhouse.io/formationbio)

## Other roles at Formation Bio

- [Senior Software Engineer II, Trial Engine](https://feeny.ai/job/senior-software-engineer-ii-trial-engine-formation-bio-new-york-xmdx1ntkdnft) — New York, NY / Boston, MA / San Francisco, CA
- [Engineering Manager, Infrastructure](https://feeny.ai/job/engineering-manager-infrastructure-formation-bio-new-york-amagy5ph1aww) — New York, NY / Boston, MA / San Francisco, CA
- [Associate Director, Data Engineering](https://feeny.ai/job/associate-director-data-engineering-formation-bio-new-york-42d1v3naj1av) — New York, NY / Boston, MA / San Francisco, CA
- [Associate Director/Director, Data Governance](https://feeny.ai/job/associate-director-director-data-governance-formation-bio-boston-xx5v9a3egg60) — Boston, MA / New York, NY
- [Director/Senior Director, Product - Applied Data Science](https://feeny.ai/job/director-senior-director-product-applied-data-science-formation-bio-new-york-1jdx3r9777my) — New York, NY / Boston, MA
- [Director, Financial Reporting](https://feeny.ai/job/director-financial-reporting-formation-bio-new-york-dnjc17wg84ew) — New York, NY / Boston, MA
- [Lead Technical Recruiter](https://feeny.ai/job/lead-technical-recruiter-formation-bio-new-york-pye3kqkgckja) — New York, NY / Boston, MA
- [Director/Senior Director of Asset Quality Assurance](https://feeny.ai/job/director-senior-director-of-asset-quality-assurance-formation-bio-boston-vfbd0h0vtcmy) — Boston, MA / New York, NY
- [Associate Director/Director, Data Science (Real World Data)](https://feeny.ai/job/associate-director-director-data-science-real-world-data-formation-bio-boston-g3kbgbvmk75j) — Boston, MA / New York, NY
- [Senior Director or Vice President, Product](https://feeny.ai/job/senior-director-or-vice-president-product-formation-bio-new-york-qb7gazwp0609) — New York, NY / Boston, MA