Job Description

• 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:
  a. Artwork Approval Process
  b. Artbrand
  c. TrackMate
  d. Labdoxx
  e. 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.

Master's Degree