Agios (agios.com) is a biopharmaceutical company committed to applying our scientific leadership in cellular metabolism to transform the lives of patients with cancer and rare genetic diseases. We are growing rapidly with an active research and discovery pipeline across both therapeutic areas. Agios has two approved oncology precision medicines and multiple first-in-class investigational therapies in clinical and/or preclinical development.
Agios is seeking a highly motivated Associate Director, GCP Quality. The candidate should be able to provide ICH/GCP leadership, consultation, and direction to Agios stakeholders regarding GCP related activities/issues. The individual should have experience with leading GCP site, vendor and CRO audits, inspection readiness activities and experience with GCP/GVP Health Authority inspections. The candidate should have the ability to identify and drive CAPAs and continuous process improvement initiatives through collaboration with their clinical counterparts.
Serve as the GCP Quality/Clinical Compliance representative for clinical study teams (CTWGs). Provide ICH/GCP guidance and clinical compliance knowledge to the CTWGs, inclusive of supporting risk identification/management, investigation/CAPA activities, and responses to internal and external audit findings.
Conduct QA reviews of project-related Clinical Development essential documents (e.g. protocols, amendments, case report forms, tables and listings, informed consents, investigator brochures, and Clinical Study Reports).
Development and oversight of the audit strategy and audit plan, with focus on GCP compliance and inspection readiness.
Plan and lead audits to determine compliance status and identify compliance risks internally, at CROs, vendors and clinical sites.
Ensure that the audit plan is implemented; provide assurances that clinical studies are of the highest quality standard and are in compliance with the requirements of company SOPs, study protocols, ICH guidelines, GCP regulations and other relevant regulations
Ensure that audit results are formally and consistently recorded, reported, trended. Ensure that corrective/preventive actions have been identified, documented and are effective.
Conduct QA audits of Regulatory submission.
Manage small team of direct reports.
Bachelor’s Degree in a scientific discipline
10+ years of experience in the pharmaceutical industry, including 5+ years in GCP Quality.
Advanced knowledge and demonstrated experience in the applicable GXP regulations, including ICH Guidelines, including E6 R(2)
In-depth knowledge of drug development processes and GCP regulations.
Advanced knowledge in the conduct and reporting of Heath Authority inspections and the translation of findings into corrective action.