# Associate Director, GMP Quality

**Company:** [Formation Bio](https://hotfix.jobs/companies/formation-bio)
**Location:** Boston, MA, New York, NY
**Role:** Other
**Salary:** $122k – $153k/yr
**Experience:** 10+ years
**Skills:** Gmp, Fda, Ema, Ich, Batch Records, Deviations, Oos, Oot, Audits, Quality Agreements, Fmea, Cmo Oversight, Biologics Manufacturing
**Posted:** 2026-07-13

> The Associate Director, GMP Quality Assurance ensures compliance for Formation Bio's biologics portfolio by reviewing GMP documents, conducting batch releases, leading investigations, auditing CDMOs, and supporting regulatory inspections. Requires 10+ years GMP QA experience in large-molecule manufacturing, bachelor's in a scientific field, and hands-on quality leadership in a dynamic environment.

## Job Description

## 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.
- Explore opportunities to integrate AI technologies to improve efficiency, compliance, and quality assurance practices.

## Requirements
- 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.

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