Senior GMP QA Manager - Remote Compliance & Audits

Beeline Medicines; Boston; On-site; PHP 9,404,000 - 12,207,000; Full time

Benefits offered by this job

Hybrid schedule

Equity incentive

Competitive benefits

Job summary

Beeline Medicines is seeking a Senior GMP Quality Assurance Manager to provide day‑to‑day QA oversight of manufacturing, testing and release activities, ensuring compliance with GMP regulations and company standards.

The role includes leading internal and external GMP audits, managing quality agreements with external manufacturers, and supporting health authority inspections, with travel ~30% and a remote work arrangement.

Qualifications

• Bachelor’s degree in a scientific or related discipline required.
• Advanced degree preferred.
• 5 years of GMP quality assurance experience in pharma/biotech.
• Experience with CMO/CDMO oversight and batch disposition.
• Knowledge of GMP regulations (FDA, EMA, ICH Q7/Q10) and QMS.

Responsibilities

• Provide GMP QA oversight of CMO/CDMO manufacturing and testing activities.
• Review and approve batch records, deviations, CAPAs, and change controls.
• Support product disposition and release activities with QA and Regulatory.
• Lead or support internal and external GMP audits, including CMO/vendor qualification audits.
• Manage quality agreements and oversight of external manufacturing partners.
• Support inspection readiness and represent QA during health authority inspections.

Skills

GMP QA oversight

Audits

Quality risk management

Communication skills

Education

Bachelor’s degree in a scientific discipline

Advanced degree preferred

Job description

Beeline Medicines is seeking a Senior GMP Quality Assurance Manager to provide day‑to‑day QA oversight of manufacturing, testing and release activities, ensuring compliance with GMP regulations and company standards.

The role includes leading internal and external GMP audits, managing quality agreements with external manufacturers, and supporting health authority inspections, with travel ~30% and a remote work arrangement.