Sr. Manager, QA Compliance
Core
Maintains GxP quality systems processes and procedures to drive quality compliance and business efficiencies in a biopharmaceutical setting.
Role type
Senior Manager, QA Compliance
Builds
Quality compliance frameworks, risk management processes, and product recall/complaint management systems for commercial biopharmaceutical products.
Domain
Biopharmaceuticals / Life Sciences
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, Quality Risk Management (ICH Q9), regulatory inspection experience, product recall management, product complaint management, CAPA execution, change control management, Veeva QMS oversight, US FDA/EU regulatory knowledge
Preferred skills
biologics industry experience, global operations experience, combination drug compliance knowledge, Joint Signal Detection (JDST) participation
Technologies
Veeva QMS
Responsibilities
Track and manage cross-functional quality records (deviations, lab investigations, change control, complaints, CAPA); maintain and trend quality metrics/KPIs to identify adverse trends; ensure Quality Risk Management process implementation; support regulatory inspections, submissions, and internal/external audits; own and execute product recall and annual mock recall processes; author and review GMP controlled documents including Quality Manual and compliance policies.
Seniority
Senior, hands-on IC with management responsibilities