Director, QA R&D - PV Audits

Role Summary

Director, QA R&D - PV Audits. Responsible for implementing a comprehensive audit program and leading a high-performing team of audit staff to assure the Pharmacovigilance (PV) system has proper quality, integrity and controls via strategic audit oversight. Ensure R&D remains in compliance with corporate policies and worldwide regulations; provide consultation to R&D leadership; and lead strategic audit programs, external audits, and inspection readiness.

Responsibilities

• Lead collaboration across R&D Quality, Safety and core PV System stakeholders to characterize the Audit landscape, routinely assess PV System risks for compliance and quality with audit methodology at strategic and tactical levels.
• Lead cross-discipline projects and implement strategies that benefit the PV System quality foundation; enable growth of the audit team through data and advanced technology to drive decision making and audit execution.
• Monitor new regulations and industry trends; ensure compliance with regulations and policies within AbbVie and with external collaborations as applicable.
• Identify and manage operational and strategic issues within the audit program with governance and escalation strategies as appropriate.
• Lead curation and maintenance of inspection-ready documentation (SOPs and evidence of execution) to support Health Authority interactions.
• Oversee timely provision of required data to ensure Product Safety Master File contains accurate audit-related data.
• Lead routine interactions with stakeholder leadership across audited functions to ensure understanding of audit targets, improvements, program changes, and performance of the audit team and auditees.
• Lead Risk Management practices tailored to the assigned audit program; connect to R&D Quality, Compliance and External Partnership leaders to drive improvements and forward-looking strategies based on internal signals, benchmarks, and regulatory advancement.
• Build a strategic, high-performing team executing audits and mitigating risks affecting on-market and development milestones; support auditee partners during external audits and inspections.
• Identify, monitor, and improve audit organization connections and utilization of Quality System Elements including Risk Management, Change Management and Exception Management (planning changes, issues, CAPA, and exceptions).
• Engage stakeholders in ongoing reviews of audit activities, issues, and achievements; create forums for QA inclusion in process improvements and proactive QA activities.
• Recruit, develop, manage, and mentor a team of Quality Professionals; define goals and development plans; conduct annual performance reviews; recommend hiring, promotion, and disciplinary action.

Qualifications

• Bachelor degree in a physical science, life science, nursing, pharmacy or equivalent experience required.
• 10+ years of pharmaceutical industry experience.
• Pharmacovigilance experience.
• 3+ years of people leadership experience, highly preferred.
• Strong people leadership and team management skills with ability to mentor, coach, and develop high-performing audit professionals and teams.
• Ability to balance adaptability with timely decision making to ensure delivery of core audit programs while leveraging innovation and technology.
• Ability to lead, prioritize and resource plan for multiple, complex, competing quality improvement projects and activities.
• Ability to lead with a change-ready mindset and cultivate a team delivering process improvement, accountability, and trust as a strategic advantage for R&D Quality.

Skills

• Quality management
• Audit program management
• Strategic and dynamic team leadership
• Critical communication
• Analytical aptitude for pharmacovigilance and quality systems

Education

• As listed in Qualifications

Additional Requirements

• Role may be remote within the US or UK; title and grading adapted to host country; compensation aligned to country of residence.