Teams at Alkermes

Lead design, implementation, governance, and continuous improvement of enterprise EHS management systems aligned to ISO 14001/45001 and PSCI. Own global policies, audit programs, CAPA closure, metrics, and reporting. Partner with site EHS and operations across GMP manufacturing and vendors, coach site teams, support change management, and drive risk reduction through audits, root cause analysis, and stakeholder influence.

Lead independent, risk-based GMP audits and oversee supplier quality governance for external manufacturers, laboratories, and logistics. Act as a Qualified Person providing regulatory oversight, supplier qualification, audit program management, risk-based decisions, inspection readiness support, and continuous improvement of QMS for EU and US GMP compliance.