Provide day-to-day Quality Assurance support for commercial and clinical drug product manufacturing activities, including review and approval of batch records, deviations, investigations, change controls, and CAPAs, ensuring decisions are scientifically sound and compliant with GMP requirements.
Serve as the primary QA liaison for assigned contract manufacturing organizations, overseeing quality agreements, performance monitoring, issue resolution and escalation, and continuous improvement activities. This includes conducting and supporting audits, evaluating quality metrics, and ensuring alignment with internal quality expectations.
Support drug product lifecycle activities, including technical transfers, process changes, validation activities, and stability programs, by providing proactive QA input and risk-based decision-making.
Lead or support internal and external audits and inspections related to drug product operations, including preparation, execution, response development, and follow-up actions.
Contribute to the continuous improvement of the Quality Management System by identifying trends, recurring issues, and opportunities to strengthen processes, training, and documentation.
Provide mentorship, guidance, and informal leadership to QA colleagues and cross-functional partners, helping to build a strong quality culture across commercial operations.

BS/BA in a relevant scientific discipline
At least ten (10) years of experience in Quality Systems and Quality Assurance processes, including development and documentation.
Minimum of two (2) years in a managerial role, including supervisory experience of QA personnel
Experience with commercial and clinical drug manufacturing and manufacturing process validation; familiarity with Federal laws and regulations affecting the pharmaceutical industry.
Comprehensive knowledge of GMP regulations, ICH, and FDA guidelines critical to sterile product manufacture of biologics.
Conduct investigations, risk assessments, complete GMP QA related forms, etc.
Five (5) years of experience in Quality Systems and Drug Product Quality Assurance, particularly in the biotech or pharmaceutical industry.
Experience with Drug Product Process Performance Qualification leading towards commercialization.
Experience with analytical method qualification/validation.
Experience as a QA Manager, including supervisory responsibilities

Senior Manager, QA – Commercial GMP

Key skills