Associate Director, Standards, Compliance & Training

Agios Pharmaceuticals Inc • Cambridge, MA

1d • $153,541 - $230,312 • Hybrid

About The Position

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 at Agios. This 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.

Requirements

• 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 drug safety or pharmacovigilance experience, including knowledge of current industry standards and benchmarks.
• Advanced knowledge of US and EU pharmacovigilance regulations for investigational and marketed products.
• Experience with pharmacovigilance processes, compliance tracking, and safety systems such as ARGUS, ARISg, or equivalent platforms.
• Experience authoring and maintaining pharmacovigilance and risk management procedures.
• Strong understanding of vendor oversight, contracts, KPIs, and key quality indicators.
• Proficiency with Microsoft Office and related business tools.
• Strong planning, process mapping, organizational, negotiation, written and verbal communication, interpersonal, and cross-functional collaboration skills.
• Demonstrated ability to balance decisions with ethics, compliance, and quality considerations.

Nice To Haves

• Advanced degree, such as a master’s degree or higher, in life sciences or a related field.
• Project management experience and/or certification.

Responsibilities

• 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.

Benefits

• Deliberate Development. Your professional growth as one of our top priorities.
• Flexibility. We’re all about individual needs. We embrace different perspectives, work styles, health and wellness approaches, care of families and productivity. When you’re at your best, we’re at our best.
• Premium benefits package. We invest in the health, wellbeing, and security of our people with a premium benefits package that is well-rounded and flexible to help meet the varied personal and professional needs of every member of our team. For more detail on the benefits we offer at Agios, visit the Inside Agios section of our website.
• Competitive and equitable performance-based compensation. This includes base salary and both short- and long-term incentives that are connected to our business strategy and vary based on individual and company performance.
• Psychological safety. We support an environment of fearlessness. We want you to share your ideas, speak candidly and take data-informed risks to help push the boundaries.
• Commitment to diversity. We strive to foster a welcoming workplace where everyone can thrive. We’re continuously looking to improve the inclusivity of our workforce.
• Commitment to community. We’re an active participant in the communities that surround us – the communities where we live, and the community of people and their loved ones in need of better treatment options for conditions that are often overlooked.

What This Job Offers

• Job Type: Full-time
• Career Level: Director