Associate Director, Standards, Compliance & Training

Kinsley Power Systems; Cambridge, Northern (MA, KY); Hybrid; USD 154,000 - 230,000; Full time

Benefits offered by this job

Premium benefits package

Flexible work arrangement

Competitive and equitable performance‑

Job summary

Agios Pharmaceuticals is seeking an Associate Director, Standards, Compliance & Training within the Medical Safety and Risk Management (MSRM) team. The role will coordinate governance, training, and documentation to ensure compliance and efficient operations across pharmacovigilance activities.

You will partner with Safety Operations and Quality Assurance to support vendor oversight, case quality expectations, and regulatory submissions, while driving continuous improvement and enterprise

Qualifications

• Health care professional qualification, such as RN or pharmacist, or BS/BA in life sciences or a related field.
• Minimum of 5 years of pharmacovigilance experience with industry standards.
• Advanced knowledge of US and EU pharmacovigilance regulations.
• Experience with pharmacovigilance processes, compliance tracking, and safety systems such as ARGUS, ARISg.
• Experience authoring pharmacovigilance and risk management procedures.
• Strong vendor oversight, contracts, KPIs and quality indicators.
• Proficiency with Microsoft Office and related business tools.
• Strong planning, communication, and cross-functional collaboration.
• Ability to balance ethics, compliance and quality considerations.

Responsibilities

• Lead MSRM compliance governance, including KPI tracking and reporting.
• Drive inspection- and audit-readiness activities with SME coordination.
• Manage MSRM quality events, CAPAs, changes and deviations.
• Coordinate quarterly Pharmacovigilance System Master File updates.
• Author and contribute to pharmacovigilance partner agreements.
• Oversee MSRM documents: SOPs, work instructions, and job aids.
• Evaluate processes to improve efficiency, accuracy, and compliance.
• Oversee safety training programs and curricula.
• Serve as business owner for MSRM SharePoint and eDMS libraries.

Skills

Pharmacovigilance

Regulatory knowledge

Vendor oversight

Microsoft Office

Cross-functional collaboration

Education

RN or pharmacist or life sciences degree

Tools

ARGUS

ARISg

Job description

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 www.agios.com and follow Agios on LinkedIn and X.

The impact you will make:

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.

What you will do:

• 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.

What you bring:

• 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.

Preferred Qualifications

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

Work Location:

Location Agnostic: Work location for this role is based on employee's individual preference. This role has the ability to be either remote in the US or hybrid in our Cambridge Headquarters. Hybrid schedules vary but are generally less than 3 days per week onsite and hybrid employees are expected to live within commutable distance to our Cambridge Headquarters. Remote employees work entirely from home except for attending Company sponsored events/ meetings. For employees who choose to work remotely, travel may be required for certain company events commensurate to the above job description.

What we will give you:

• 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.
  • The current base salary range for this position is expected to be between $153,541 and $230,312 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators.
• 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.

Interested in learning more about what makes our culture unique? Visit the Inside Agios section of our website.