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Role Description

Agios Pharmaceuticals is searching for a dynamic Manager, Standards Compliance & Training (SCT) to join our growing Medical Safety & Risk Management team. The Manager, 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).

• 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
• Support the execution of internal and external audits and inspections
• Ensure MSRM’s state of inspection readiness at all times

What you will do

• Participate in the development, implementation and/or management of robust PV compliance monitoring activities
• Contribute to coordination of activities for successful conduct of PV internal and external audits
• Participate in inspection readiness activities
• Plan, schedule and prepare compliance data for monthly MSRM internal compliance meetings
• Manage MSRM non-conformances from investigations through CAPA development and implementation
• Develop, maintain, and conduct PV-related trainings
• Identify areas for continuous improvement regarding MSRM related procedural documents
• Maintain MSRM’s strategy for PV regulatory intelligence management and change control processes
• Liaise with Agios Training to maintain MSRM training matrix/plan
• Develop and maintain MSRM central electronic repositories and dashboards
• Support departmental budget activities

Qualifications

• 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

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
• 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

What we will give you

• Deliberate Development: Your professional growth as one of our top priorities
• Flexibility: Embrace different perspectives, work styles, health and wellness approaches
• Premium benefits package: Invest in the health, wellbeing, and security of our people
• Competitive and equitable performance-based compensation
• Psychological safety: Support an environment of fearlessness
• Commitment to diversity: Foster a welcoming workplace where everyone can thrive
• Commitment to community: Active participant in the communities that surround us