Associate Director, Quality Operations

📋 Description

• Provide QA oversight of production, labeling, testing, warehousing, and distribution.
• Review and approve quality agreements, master records, specs, and validation docs.
• Review batch production and QC records to verify procedures and specs are met.
• Prepare and approve batch disposition packages.
• Review quality system records (deviations, OOS, CAPAs, complaints).
• Lead or participate in meetings as CMC Quality SME for GMP, GDP, and good documentation.

🎯 Requirements

• Bachelors degree.
• 8+ years in pharma/biotech quality roles.
• Experience authoring IND CMC sections and regulatory filings.
• Knowledge of FDA cGMP, Eudralex, and ICH guidelines.
• Ability to coordinate with internal and external partners to ensure compliance.
• Travel up to 10% for on-site reviews.

🎁 Benefits

• Remote work opportunities within the United States.
• Travel to Cambridge, MA several times per year.
• Accommodations available during selection process.
• Equal Opportunity Employer.