Director, QA R&D - PV Audits

Director Of Pharmacovigilance Auditing

Purpose : The Director of Pharmacovigilance Auditing is responsible for implementing a comprehensive audit program and leading a high-performing team of audit staff to assure AbbVie's Pharmacovigilance (PV) system has proper quality, integrity and controls via strategic audit oversight. Audit management includes auditing, people leadership / development and compliance reporting where required.

This role will ensure that R&D remains in compliance with the corporate policies and applicable worldwide regulations. The role includes strategic leadership of Audit Programs to assure compliance, external audit of AbbVie and inspection readiness across the scope of our Portfolio, global footprint and the foundational connections of our complex PV System. Provide consistent and aligned consultation to R&D leadership stakeholders from multi-functional interactions with a focus on audit management, risk decisions, metric / process reporting with a data-driven, comprehensive quality perspective. Influencing the decision-making process to drive foundational quality requirements into process, issue and risk management and inclusion within process improvement initiatives.

This position is accountable to the leader of the Internal Audit function for R&D Quality. The decisions and recommendations made by the individual will directly assess the controls in place and will impact actions assuring adherence to applicable regulations and thereby promote the continued success of R&D. Core competencies expected for this role : Quality management, Audit program management, Strategic and dynamic team leadership, Critical communication skills, Functional expertise and Analytical aptitude for the subject matter.

Responsibilities :

• Lead collaboration across R&D Quality, Safety and core PV System stakeholders to ensure the Audit landscape is well characterized, risks to the PV System are routinely assessed for compliance and quality with audit methodology applied both at the Strategic and Tactical level.
• Lead cross-discipline projects and implement strategies that directly benefit the PV System quality foundation, enable strategic growth of the audit team via strength in the application of 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 in partnership with external collaborations as applicable.
• Identify and manage support of operational and strategic issues within the audit program with governance and escalation strategies applied as appropriate.
• Lead the curation and maintenance of inspection ready documentation (SOPs and Evidence of execution) to assure any team member asked to support a Health Authority interaction can present the PV Audit function.
• Oversee the timely and comprehensive provision of required data and information to ensure the Product Safety Master File contains accurate audit-related data.
• Lead routine interactions with stakeholder leadership across the audited functions to ensure understanding of audit targets, areas requiring improvement, strategic program changes and performance of the audit team and auditees.
• Lead Risk Management practices that are tailored to the assigned audit program and ensure strong connection to R&D Quality, Compliance and External Partnership leaders, to drive improvements and forward-looking strategies for audit priorities based on internal signals, industry benchmarks and Regulatory advancement.
• Build a strategic, high-performing team executing audits, identifying and helping prevent risks from impacting on-market and development milestones, while increasing success of our team and auditee partners during external audits and inspections.
• Identify, monitor, and ultimately improve the audit organization connections and utilization of critical Quality System Elements including Risk Management, Change Management and Exception Management (inclusive of planned changes, issues, CAPA and exceptions).
• Engage stakeholders in on-going reviews of the activities, issues and achievements related to audit performance by auditees, build forums to ensure QA inclusion for process improvements and team awareness of proactive QA activities.
• Recruit, develop, manage, and mentor a team of Quality Professionals, including defining goals and development plans for the group. Provide annual performance reviews for direct reports. Recommend hiring, promotion and disciplinary action for staff.

The role can be remote within the US or UK.

Title and grading will be adapted to the host country. Compensation will be to your country of residence.

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 leader experience, highly preferred.

Strong people leadership and team management skills with the ability to mentor, coach, and develop high-performing audit professionals and teams.

Ability to balance adaptability with consistent and timely decision making to ensure detailed delivery of core audit programs while seeking innovation and effective deployment of the people, processes and technology utilized.

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 who consistently deliver process improvement, have accountability and build trust as a strategic advantage for R&D Quality.