# Associate Director, GMP Quality

**Company**: Formation Bio
**Location**: Boston, MA; New York, NY
**Work arrangement**: hybrid
**Experience**: senior
**Job type**: full-time
**Salary**: $122,000 - $152,500
**Category**: Operations
**Industry**: Healthcare

**Apply**: https://job-boards.greenhouse.io/formationbio/jobs/8043939?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_b1aa43a3-b3d

## Description

Formation Bio is seeking an Associate Director, GMP Quality Assurance to ensure that all GMP-regulated activities are executed in compliance with regulatory requirements, industry standards, and company procedures.

The ideal candidate is a hands-on quality leader with strong communication skills and the ability to pivot in a dynamic environment. 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

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

Total Compensation Range: $122,000 - $152,500

## Skills

### Required
- GMP Quality Assurance
- Pharmaceutical Manufacturing
- Regulatory Compliance
- Quality Control
- Risk Management

### Nice to have
- Artificial Intelligence
- CMO Oversight
- Virtual Manufacturing Models

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Source: [Apply at job-boards.greenhouse.io](https://job-boards.greenhouse.io/formationbio/jobs/8043939?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)