Safety Compliance Director - Remote

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 life cycle of all products. As Director, Safety Compliance, this is a highly visible role that provides oversight, leadership and strategic direction to the PPS organization, specifically in relation to PV system oversight and change management.

In Short

• Build strong strategic partnerships with key internal stakeholders across Clinical Sciences and R&D.
• Translate departmental vision and strategy into actionable priorities for the Safety Compliance team.
• Lead complex cross-functional compliance activities with vigilance-related impact.
• Accountable for PV system compliance oversight and GxP change management.
• Drive analysis, impact assessment, and change planning.
• Create and maintain Global PV system performance and compliance metrics.
• Establish flexible processes to manage organizational changes effectively.
• Deliver strategy execution for audits and inspections.
• Perform leadership activities including hiring, coaching, and performance reviews.

Requirements

• Bachelor’s Degree in Science, Health Related, or Quality field; Advanced Degree preferred.
• Pharmaceutical industry experience in Quality System Management.
• Knowledge of global vigilance compliance requirements (e.g., ICH, FDA, EMA).
• Proven ability to manage compliance risks.
• Experience leading cross-functional teams on complex projects.
• Strong leadership presence and influencing skills.

Benefits

• Equal opportunity employer committed to integrity and innovation.
• Focus on transforming lives and serving the community.