Senior Manager/AD, GCP & GVP, QA

The Impact You Will Make

Agios Pharmaceuticals is searching for a dynamic Senior Manager/Associate Director, 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.

Responsibilities

• Collaborate 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.

Requirements

• Bachelor’s degree in a scientific discipline preferred or Associate’s degree with commensurate experience; advanced degree preferred
• Sr Mgr level: Minimum 4-6+ years of progressive experience working within a clinical, regulatory or quality environment in the pharmaceutical or biotechnology industry
• AD level: 6-8 years of progressive experience working within clinical, regulatory or quality environment in the pharmaceutical or biotech 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

Qualifications

• Concerned that you don’t check off every box in the requirements listed above? Please apply anyway!

Benefits

• Deliberate Development
• Flexibility
• Premium benefits package
• Competitive and equitable performance-based compensation
• Psychological safety
• Commitment to diversity
• Commitment to community