Associate Director, Standards, Compliance & Training

Associate Director, Standards, Compliance & Training, MSRM

Who we are:

At Agios, we are fueled by connections to transform rare diseases. We foster an inclusive, collaborative culture – one that sparks bold thinking and strengthens our connections with each other and with the rare disease communities we serve. We embrace diverse backgrounds with respect, active listening, and a commitment to inclusion – because our differences shape how we hire, collaborate, and innovate.

Our team’s proven track record of executional excellence, combined with our depth of expertise and dedication, enables us to develop innovative medicines that reflect the priorities of rare disease communities. Our commitment is more than scientific – it’s deeply personal, grounded in the meaningful connections we have built. To learn more, visit  and follow Agios on Linked In and X .

Agios Pharmaceuticals is searching for a dynamic Associate Director, Standards, Compliance & Training, to join our Medical Safety and Risk Management team. We want someone who cares about this important work, and who’s driven to connect to our mission of helping these patient communities. The Associate Director, Standards, Compliance & Training will play a key role within the Medical Safety and Risk Management (MSRM) function s role will engage will all members of the MSRM team to ensure the planning and execution of the various key work streams and deliverables within the group.

This role will report directly to the Sr. Director of Safety Data Operations & Compliance at Agios.

• Lead MSRM compliance governance activities, including monthly and quarterly reviews, metric and KPI tracking, slide preparation, meeting minutes, and ongoing refinement of compliance reporting.
• Drive departmental inspection- and audit-readiness activities, including SME coordination, training support, request tracking, quality control, timely response development, and completion of related commitments.
• Manage MSRM quality events, CAPAs, effectiveness checks, change controls, and deviations to ensure timely closure and sustained compliance.
• Coordinate quarterly updates to required Pharmacovigilance System Master File documents for Agios products.
• Author and contribute to pharmacovigilance partner agreements and support effective external partner relationships.
• Oversee MSRM controlled documents, including SOPs, work instructions, job aids, and related procedures; track status, support approvals, and author or revise content as needed.
• Evaluate pharmacovigilance processes to improve efficiency, accuracy, and compliance, including implementation of metrics and reporting to monitor outcomes across the portfolio.
• Manage safety reporting training, including new-hire training, department training completion tracking, enterprise compliance metrics, onboarding and offboarding support, and maintenance of training roles and curricula.
• Serve as business owner for MSRM SharePoint sites and the eDMS department library, including organization, content management, user access, and permissions.
• Partner with Safety Operations and Quality Assurance to support vendor compliance with global regulations, partner agreements, case quality expectations, and submission timelines.
• Support MSRM budget and long-range planning activities, including quarterly reforecasts, annual budget reviews, contract initiation, change orders, and contract closeout.
• Contribute to departmental initiatives, technology upgrades, and system acquisitions to support compliance, operational effectiveness, and business continuity.

• Health care professional qualification, such as RN or pharmacist, or BS/BA in life sciences or a related field.
• Minimum of 5 years of relevant…