Experience with U.S. labeling systems, artwork management platforms, or regulatory labeling environments within a regulated industry is highly desirable.
Prepare, review, and revise Standard Operating Procedures (SOPs), conduct risk assessments, and ensure effective and compliant implementation.
Demonstrate strong experience working within Quality and Compliance Management System environments.
Act as the Department Training Coordinator, ensuring timely planning, execution, and documentation of training activities.
Ensure labeling compliance within the labeling department as well as across interfacing internal and external functions.
Ensure timely completion of all activities within the Global Regulatory Labeling department, meeting business, regulatory, and quality expectations.
Serve as the single point of accountability for end-to-end management, governance, and successful delivery of all ALI (Amneal Labeling Intelligence) initiatives. This is a global role with responsibility for planning, execution, and oversight of ALI initiatives across all regions.
Ensure timely execution of initiatives while maintaining regulatory and quality compliance, effective risk mitigation, and consistent adoption across all ALI digital systems, including future labeling digitalization efforts.
End-to-End Initiative Ownership Own and manage the full lifecycle delivery of ALI initiatives, including but not limited to:
Artwork Approval Process
Artbrand
TrackMate
Labdoxx
Other current and future ALI-related platforms and tools
Drive comprehensive project planning, execution, monitoring, and closure across development, validation, and implementation phases.
Ensure strict adherence to approved timelines, defined scope, quality standards, and regulatory compliance requirements.
Facilitate strong cross-functional alignment and decision-making across Regulatory Affairs, Quality, IT, Business stakeholders, and external partners through established governance frameworks.
Manage vendor relationships, including oversight of deliverables, performance tracking, issue resolution, and escalation management.
Drive system adoption and operational readiness through structured change management, user training coordination, stakeholder communication, and post-implementation support.
