Manager, Quality Operations

📋 Description

• Provide QA oversight of Drug Product and Finished Drug Product production activities.
• QA review/approval on sterile product validation docs, specs, and stability plans.
• Review batch production and QC records to ensure procedures followed and specs met.
• Prepare and/or approve batch disposition packages.
• QA review on deviations, OOS, CAPAs, and complaints.
• Lead QA meetings as SME for GMP, GDP, and Good Documentation Practice.

🎯 Requirements

• Bachelor's degree with 5+ yrs in Quality Ops/QC/MSAT; or advanced degree with 3+ yrs.
• 3+ yrs sterile/aseptic manufacturing QA/QC/MSAT experience.
• Author NDA CMC sections and regulatory filings (FDA cGMP, Eudralex, ICH).
• Ability to work with all levels and external contract providers.
• Travel up to 10% within the US.
• Environmental monitoring and serialization experience (preferred).

🎁 Benefits

• Remote work opportunities within the United States.
• Occasional travel to Cambridge, MA, several times a year.