Senior Manager, GCP & GVP, QA

Senior Manager, GCP & GVP, QA

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 . The impact you will make:
Agios Pharmaceuticals is searching for a dynamic Sr. Manager, GCP & GVP Quality Assurance (QA) to join our growing GCP & GVP Quality 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 Sr. Manager, GCP & GVP QA will be responsible for ensuring quality assurance and compliance of Agios Pharmacovigilance (PV) System and Agios sponsored interventional and non-interventional clinical trials in accordance with applicable Good Pharmacovigilance Practices (GVP) and Good Clinical Practice (GCP) regulatory requirements (e.g., FDA, ex-US, country specific), ICH GCP/GVP Guidelines, Agios Standard Operating Procedures (SOPs), and current industry standards and practices.

They support, maintain and ensure effectiveness of quality programs and documentation to assure compliance with GVP and GCP and inspection readiness.

What you will do:

Responsible for collaborating cross-functionally to develop risk-based GCP/GVP internal and external audit program and annual audit plans. Conduct and/or oversee consultant auditors in the conduct of GCP/GVP audits of clinical trial internal and PV processes, GCP/GVP vendors, clinical investigator sites, clinical study documents and trial master files in accordance with annual audit plans. Provide timely GCP/GVP quality guidance and partner with key stakeholders to resolve compliance issues and support functions in the quality event management process, protocol deviations, risk management, issue escalation and CAPA development.

Actively participate in the Clinical Trial Working Groups (CTWG) as the Quality Representative and serve as liaison to other GxP Quality teams as needed. Advise teams on controlled document development to ensure adherence to ICH and GCP/GVP guidelines and alignment with Agios Quality Policy and QMS. Support preparation, coordination and management of Health Authority inspections including Sponsor and Investigator Site Inspections.

What you bring:

Bachelor's degree in a scientific discipline preferred or Associate's degree with commensurate experience; advanced degree preferred Minimum 4-6+ years of progressive experience working within a clinical, regulatory or quality environment in the pharmaceutical or biotechnology industry Must have applied experience in quality assurance auditing and applicable regulations Prior experience in regulatory inspections preferred Ability to establish collaborative working relationships with internal and external stakeholders Self-motivated and able to effectively prioritize and manage multiple projects Excellent time and project management skills Effective written and verbal communication skills with the ability to communicate clearly and concisely Ability to take ownership of specific projects, and to effectively lead and work with team members on projects as required Ability to travel (~25%) domestically and internationally Concerned that you don't check off every box in the requirements listed above?

Please apply anyway! At Agios, we value each other's differences and recognize that teams thrive when everyone brings their unique experiences to the table. We are dedicated to building an inclusive, diverse, equitable, and accessible environment where all employees can bring their…