Responsibilities
- Drive the implementation of the Global Quality vision, policies, processes, and decisions
- Work with stakeholders to identify, communicate, and reduce compliance risks
- Strengthen partnerships with key business leaders and stakeholders
- Support and lead quality and compliance projects and objectives
- Monitor regulatory changes and recommend proactive compliance adjustments
- Execute GVP Compliance processes and best practices
- Conduct GVP audits and support the Global GVP Audit Program
- Serve as a GVP compliance core team member on regulatory inspection teams and assist with mock readiness activities
- Provide insights to continuously improve the GVP Compliance Audit Program
- Contribute to updates of the Pharmacovigilance System Master File (PSMF)
- Contribute to the Risk Evaluation and Mitigation Strategies (REMS) compliance program
- Help build a team that ensures GVP compliance and promotes a culture of teamwork and mutual respect
- Mentor and support junior staff development to reach their full potential
Requirements
- 8+ years of experience in a regulated healthcare industry, including a quality and compliance role
- Working knowledge of FDA, EMA, and global PV regulations, and application of Good Pharmacovigilance Practices (GVP), ICH, and GCP regulations
- Experience in Pharmacovigilance (PV) within Quality and Compliance
- Experience executing or managing Health Authority Inspections
- Experience executing or managing R&D Audits and GVP Audit Program
- Experience identifying optimal strategies for executing a GVP audit program with internal auditors and external consultants
- Experience navigating and understanding a quality management system
- Core competencies in strategic thinking, agility, prioritization, communication, and decision-making
- Strong verbal, written, and oral communication skills, with ability to present to Senior Leadership
- Ability to work independently and adapt to rapidly changing priorities
- Strong computer skills, including MS Suite and interfacing with Quality Management Systems
- Bachelor's Degree in a life science field
Nice to Have
- Experience with Business Development partnerships, mergers, or acquisitions
- Exposure to any phase of pharmaceutical drug development or post-marketing surveillance
- Awareness and understanding of core PV responsibilities such as risk management, risk minimization measures, signal management, and case processing
- Compliance oversight of REMS Program(s)
- Master's degree is a plus
Work Arrangement
Hybrid — Dublin
Other
- Shift will be 8 hours per day. If EU employee identified, shifts include at least 2 days per week with required partial overlap with US EST and PST hours of operation.
- May travel up to 25%+ of the time
