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 PV system has proper quality, integrity and controls via strategic audit oversight. Ensure R&D compliance with corporate policies and worldwide regulations, and provide consultation to R&D leadership on audit management, risk decisions, and quality improvements.

Responsibilities

• Lead collaboration across R&D Quality, Safety and core PV System stakeholders to characterize the Audit landscape and routinely assess risks to the PV System for compliance and quality
• Lead cross-discipline projects and strategies that benefit the PV System quality foundation and enable growth of the audit team using data and advanced technology
• 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 the curation and maintenance of inspection-ready documentation (SOPs and evidence of execution) for Health Authority interactions
• Oversee timely provision of data to ensure Product Safety Master File contains accurate audit-related data
• Lead routine interactions with stakeholder leadership to ensure understanding of audit targets, improvements, and performance of the audit team and auditees
• Lead Risk Management practices tailored to the audit program, connecting to R&D Quality, Compliance and External Partnership leaders to drive improvements and forward-looking strategies
• Build a strategic, high-performing team executing audits and improving auditee success during external audits and inspections
• Identify and improve connections and utilization of Quality System Elements including Risk Management, Change Management and Exception Management
• Engage stakeholders in ongoing reviews of audit activities and achievements, fostering QA inclusion for process improvements
• Recruit, develop, manage, and mentor a team of Quality Professionals; set goals, provide performance reviews, and manage staffing actions

Qualifications

• Bachelor degree in a physical science, life science, nursing, pharmacy or equivalent experience
• 10+ years of pharmaceutical industry experience
• Pharmacovigilance experience
• 3+ years of people leader experience (highly preferred)
• Strong people leadership and team management skills; ability to mentor, coach, and develop high-performing audit professionals
• Ability to balance adaptability with timely decision making to deliver core audit programs while leveraging people, processes, and technology
• Ability to lead, prioritize, and resource plan for multiple, complex quality improvement projects
• Change-ready mindset; ability to foster 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 skills
• Functional expertise in PV and QA
• Analytical aptitude for subject matter

Education

• As required by qualifications above (Bachelor degree in a physical science, life science, nursing, pharmacy or equivalent)

Additional Requirements

• The role may be remote within the US or UK; compensation adjusted to host country