Technical Lead – Quality and Regulatory IT Systems

Akorn, Inc

Job Description

SUMMARY:
Lead – Quality and Regulatory IT Systems is a strategic, enterprise role that is responsible for driving projects and managing platform operations across the organization to maximize the value of IT technology investments. Through direct collaboration with the Quality organization, the incumbent will define, develop, and deliver efficient solutions that maximize business value. He/she will be recognized as a key contributor to the Quality and IT programs with a mindset that focuses on the key areas of people, process and technology in order to drive business transformation. 

ESSENTIAL FUNCTIONS:

  • Drive the successful adoption of the Veeva quality platforms across the Akorn enterprise utilizing knowledge of the Veeva Vault platform and expertise of pharmaceutical quality operations.
  • Map business processes to capture business requirements and perform fit-gap analysis to the harmonized future state.  Conduct root cause analysis and identify solutions to close gaps.
  • Facilitate continuous improvement opportunities in order to optimize processes and remove inefficiencies, aligning Akorn towards industry best practices.
  • Lead as a key member of the Veeva implementation program, acting as a change agent and liaison between key business units (QA, DI, QC, RA, and R&D, internal IT teams and vendor resources.  
  • Drive release management for Veeva Vault software releases, including risk assessment, testing coordination, and post release configuration items.
  • Function as the primary contact and escalation point for the Veeva platform issues in support of local site business administrators and end users.
  • Assess various quality and regulatory applications and practices (e.g., training, RIM, pharmacovigilance, and other as needed) to assess effectiveness and develop roadmap based on impact and priority.  Lead initiatives to enhance associated business processes and align to corporate standards

Job Requirements

 

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