ICompany Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn, and TikTok.
Job Description
Job Overview
The purpose of this role is to provide leadership within the Safety Compliance organization to develop, implement, maintain, and monitor an optimized Quality Management System for the Pharmacovigilance and Patient Safety (PPS) organization and Affiliate Safety Staff, that at a minimum meets global regulatory legal requirements and standards. The scope extends to Pharmacovigilance (PV) activities worldwide and spans the product lifecycle. As Director, Safety Compliance, this is a highly visible role that provides oversight, leadership, and strategic direction to the PPS organization, specifically regarding PV system oversight and change management.
Key Responsibilities
* Build strong strategic partnerships with key internal stakeholders across Clinical Sciences and the broader R&D organization.
* Leverage relationships to advance organizational goals and priorities. Translate departmental vision and strategy into actionable strategic priorities for the Safety Compliance: Compliance Oversight team, and oversee implementation.
* Lead complex, high-impact, cross-functional/global compliance activities and initiatives that impact vigilance-related aspects of PPS and AbbVie. Provide strategic advice to stakeholders to ensure compliant processes and solutions.
* Lead PPS strategy for PV system compliance oversight, including significant changes to the PV system and associated GxP change management.
* Be accountable for driving analysis, impact assessment, change planning, risk identification and mitigation, action plans, trending, and effectiveness assessments.
* Maintain the Global PV system performance and compliance metrics framework.
* Create flexible and resilient processes to manage organizational and business changes effectively; delegate with oversight to empower teams; foster a decision-making climate.
* Execute regional strategies for audits and inspections in alignment with the Safety Compliance Management team.
* Perform leadership activities including hiring, onboarding, coaching, performance reviews, and career development to maximize team potential. Foster a culture of transparency, inclusion, innovation, and integrity.
Qualifications
* Bachelor's Degree in Science, Health, or Quality-related field. Advanced Degree preferred or equivalent experience.
* Experience in the pharmaceutical industry within Quality System Management on a global scale.
* Knowledge of Quality Systems and global vigilance compliance requirements (e.g., ICH, FDA, EMA), including regulations affecting pharmaceuticals, biologics, and devices.
* Proven ability to identify, assess, and manage compliance and business risks proactively.
* Experience leading cross-functional teams on complex projects with advanced influencing skills. Ability to manage complex issues and influence senior management.
Additional Information
AbbVie is an equal opportunity employer committed to integrity, innovation, community service, and transforming lives. We provide accommodations for applicants seeking assistance. For more details, visit here and here. #J-18808-Ljbffr