Sr. Associate III, Compliance - QRM Lead
Core
Operational leadership for Biogen's RTP drug substance manufacturing site, focusing on quality risk management, inspection readiness, and compliance systems.
Role type
Senior IC Quality Risk Management Lead
Builds
Inspection-ready manufacturing site aligned with global regulatory expectations
Domain
Pharmaceutical manufacturing / Quality Assurance
Required skills
Quality Assurance experience, cGMP regulations knowledge, risk management, change control, deviation management, inspection readiness, data analysis, stakeholder influence
Preferred skills
Master's degree, site-wide QRM program leadership, regulatory inspection support, cross-functional team influence, data-driven decision making
Responsibilities
Lead and manage the site Quality Risk Management (QRM) program, Maintain and oversee QRM repositories, Serve as the site Subject Matter Expert (SME) for risk management during audits, Drive inspection management activities, Lead implementation of risk management practices, Facilitate governance meetings, Support development of QRM training
Seniority
Senior, Management
