Associate Director, GMP Quality

Scorpion Therapeutics; Town of Boston (NY); Hybrid; USD 160,000 - 210,000; Full time

Benefits offered by this job

Restaurant d'entreprise

Indemnités de stage/alternance

Job summary

Scorpion Therapeutics seeks an Associate Director, GMP Quality Assurance to provide global GMP oversight for biologics manufacturing, testing, and packaging. You will lead document reviews, investigations, internal audits, and supplier qualification to ensure regulatory readiness.

The role emphasizes AI-enabled QA improvements, strong leadership, and collaboration with cross-functional teams in a hybrid NYC/Boston setting.

Qualifications

• Bachelor's degree in Chemistry, Biology, Engineering, or Pharmaceutical Sciences.
• 10+ years in GMP QA within biologics/large-molecule manufacturing.
• Deep knowledge of FDA, EMA, ICH standards.
• Excellent communication, documentation, and leadership skills.
• Experience with CMO oversight or virtual manufacturing models.

Responsibilities

• Review and approve GMP documents.
• Support investigations of deviations and OOS/OOT results.
• Conduct internal audits.
• Qualify external suppliers and CDMOs.
• Maintain quality agreements.
• Prepare for regulatory inspections.
• AI integration to enhance QA processes.

Skills

GMP QA experience

Biologics manufacturing

Regulatory standards

Leadership

CMO oversight

AI integration

Education

Bachelor's in Chemistry/Biology/Engineering/Pharmaceutical Sciences

Job description

Role

Associate Director, GMP Quality Assurance, leading quality oversight for biologics manufacturing, testing, and packaging to ensure compliance with global GMP regulations.

Responsibilities

• review and approve GMP documents
• support investigations of deviations and OOS/OOT results
• conduct internal audits
• qualify external suppliers and CDMOs
• maintain quality agreements
• prepare for regulatory inspections

Focuses on integrating AI technologies to enhance QA processes.

Requirements

• Bachelor's in Chemistry, Biology, Engineering, or Pharmaceutical Sciences
• 10+ years in GMP QA within biologics/large-molecule manufacturing
• deep knowledge of FDA, EMA, ICH standards
• strong communication, documentation, and leadership skills
• experience with CMO oversight or virtual manufacturing models

High Value Keywords

• biologics
• large-molecule GMP manufacturing
• quality investigations
• supplier qualification
• regulatory compliance
• AI integration

Work Setup

hybrid NYC/Boston; willingness to relocate or commute.

Travel

not specified