Manager, Standards, Compliance & Training (SCT), MSRM

Agios Pharmaceuticals Inc • Cambridge, MA

19h • Remote

About The Position

Agios Pharmaceuticals is searching for a dynamic Manager, Standards Compliance & Training (SCT) to join our growing Medical Safety & 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 Manager, Standards Compliance & Training (SCT) will be responsible for driving MSRM quality and compliance activities in the successful implementation of aspects of a strong GVP/GVC Quality Management System (QMS). In this capacity, the Manager, SCT will be expected to lead training material development and MSRM curricula maintenance; oversee MSRM quality event and CAPA management and implementation; collaborate with cross-functional stakeholders to maintain procedural documents current and identify areas of continuous improvements; and support the execution of internal and external audits and inspections as well as ensure MSRM’s state of inspection readiness at all times. The Manager, SCT will work closely with the Sr. Director MSRM Safety Data Operations & Compliance, MSRM sub-functions, GVP/GCP Quality and cross-functional colleagues and will be an integral part of Agios’ MSRM team.

Requirements

• Bachelor’s degree in a Life Sciences discipline, Nursing or Pharmacy or significant industry experience in Drug Safety/Pharmacovigilance
• Minimum of 5 years' experience in Drug Safety/Pharmacovigilance
• Experienced and demonstrated success in the development and implementation of compliance processes in a pharmacovigilance setting
• Robust knowledge of global regulations governing Pharmacovigilance for products in clinical development and post-marketing.
• Ability to multi-task in a high-paced, fast-moving environment with changing priorities
• Attention to detail, results-oriented and persistent with excellent organizational and project management skills.
• Strong interpersonal skills and the ability to effectively work individually and within a cross-functional team
• Solid written and oral communication skills
• Excellent MS Office, Co-Pilot and SharePoint skills.
• Occasional travel (up to 10%) for conferences, inspections, meetings and professional development activities including on-site Agios meetings.

Responsibilities

• Participate in the development, implementation and/or management of robust PV compliance monitoring activities with respect to Individual Case Safety Reports (ICSRs), company-wide safety training and MSRM relevant personal training, new and periodic procedural document development and review, safety governance activities and other relevant areas of PV System.
• Contribute to coordination of activities for successful conduct of PV internal and external audits such as ensuring provision of pre-audit requests, ensure SME availability and provision of document requests.
• Participate in inspection readiness activities such as tracking of inspection document request tracking, quality review and provision of document requests during inspection and maintenance of department inspection readiness toolkit.
• Plan, schedule and prepare compliance data for monthly MSRM internal compliance meetings and partner with GCP/GVP QA to provide input to quarterly Quality Management Review (QMR) meetings.
• Manage MSRM non-conformances beginning with investigations through CAPA development and implementation to ensure timely closure of records and effectiveness checks. In addition, process records in Agios’ eQMS in collaboration with other MSRM functions, GVP/GCP Quality and other cross-functional stakeholders.
• Develop, maintain, and conduct PV-related trainings and maintain records for internal Agios staff and external suppliers in collaboration with Agios training.
• Identify areas for continuous improvement with regards to MSRM related procedural documents and ensure adequate input from MSRM and other cross-functional SMEs to develop/update documents, as applicable.
• Maintain MSRM’s strategy for PV regulatory intelligence management and change control processes.
• Liaise with Agios Training to maintain MSRM training matrix/plan to ensure appropriate and applicable training of PV staff.
• Develop and maintain MSRM central electronic repositories (eg, SharePoint, Veeva) and dashboards.
• Support departmental budget activities.

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: Manager