Senior Change Control Analyst

2 weeks ago


Lansdale, United States Kelly Science, Engineering, Technology & Telecom Full time

Senior Change Control AnalystJob Description: Analytical Research & Development (AR&D) - Responsible for the strategic oversight and tactical operations of analytical method validation for commercialization of large molecules (Biologics and Vaccines). The team is seeking a motivated candidate to provide global analytical change control support for pipeline products within biologics and vaccines. The candidate with a preferred change control background will support global analytical changes (e.g. method and specification establishment and revisions) impacting pipeline commercialization.Primary Responsibilities:Manage end-to-end analytical change control activities associated with commercialization and ensure change control compliance with all regulatory expectations and global procedures.Partnering with key stakeholders in Regulatory, Analytical, Technology, Supply Chain, Operations, and Quality to coordinate assessments and approval of analytical change controls. Develop change strategy through creation of change plan and tasks and maintain end-to-end oversight to drive progress and escalate where required. Required Experience and Skills: Experience and understanding of change control environment and systems Work independently and within cross-functional teams.Effective organization to multi-task and manage multiple projects Strong collaborative and communication skills Effective written and oral communication skillsEducation: BS degree required, concentrations in life sciences, engineering or related relevant discipline with 4+ years of relevant industry experience.



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