Senior Manager/Associate Director, GCP Auditor
Agios is a biopharmaceutical company focused on providing medicines for some of the world’s most challenging diseases.
We’re committed to applying our scientific leadership in cellular metabolism to transform the lives of patients with genetically defined diseases (GDD), encompassing both rare and more common diseases, and mining the extensive potential in the PK platform.
We are leading the way in advancing PKR activation for hemolytic anemias, including pyruvate kinase (PK) deficiency, thalassemia and sickle cell disease, and have demonstrated a strong commitment to these patient communities.
We continue to foster a productive research engine that yields new insights and potential therapeutic approaches.
We’re a company that cares about our work, each other, and the people who are counting on us the most.
We’re inspired to think big and welcome the different perspectives and backgrounds needed to deliver extraordinary results.
We’re driven to be our best selves, together, so we can reach for the Other Side of Possible.
Agios is seeking a highly motivated Sr.
Manager/Associate Director, GCP Auditor.
This position will ensure that clinical studies are conducted in accordance with ICH and GCP guidelines, applicable regulatory requirements and Agios’ processes and SOPs.
The individual should have experience leading and independently conducting audits of clinical investigator sites, GCP vendors, internal processes, clinical study documents and trial master files.
This role should also have experience with GCP Health Authority inspections and should be able to support ongoing inspection readiness activities.
Remote candidates are welcome to apply!
Responsibilities:
- Develop and execute GCP audit plans
- Lead and conduct GCP audits of vendors, clinical investigator sites, internal processes, clinical study documents and trial master files in accordance with audit plans
- Serve as the GCP Quality/Clinical Compliance representative for clinical study teams
– Ensure clinical studies are performed in accordance with study protocols and ICH GCP guidelines and relevant regulatory requirements - Provide quality oversight to Clinical Trial Working Groups (CTWGs), inclusive of supporting risk identification/management, investigation/CAPA activities, and responses to internal and external audit findings
- Support preparation, coordination and management of regulatory agency inspections including Sponsor and investigator site inspections
Requirements:
- Bachelor’s Degree in a scientific discipline; advanced degree preferred
- 8-10 years of progressive experience working within a clinical, regulatory or quality environment in the pharmaceutical or biotechnology industry with a minimum of 3 years being in clinical quality environment; Level will be determined based on experience.
- Must have applied experience in GCP quality assurance auditing and GCP regulations
- Prior experience in GCP sponsor and site inspections required
- Advanced knowledge in the conduct and reporting of Heath Authority inspections and the translation of findings into corrective action
- 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