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Launch Change Control Manager – Dublin – 6 months

Nicholas Howard Limited are delighted to be recruiting for a new and exciting role as a Launch Change Control Manager based in Dublin.

Job Summary

The Supply Launch Change Control Manager will initiate, plan and execute Launch and Supply Change Controls to support externally sourced biologics products in all global regions.

  • Lead new product launches change control process for global regions in support of growth objectives and to ensure compliant delivery of external supply launch change projects.
  • Be responsible for the timely completion of goals and objectives including ensuring all relevant launch and change management systems and processes are in place and maintained for externally sourced biologics products.
  • Maintain productive and collaborative relationships and communications internally as well as with the CMO’s in support of the already established Biologics External Supply Operations team.
  • Utilise project management tools, schedules, plans and trackers to support product delivery needs and project tech transfer support.
  • Be responsible (as part of the Biologics External Supply Operations) for continuous improvement of compliance and change management to ensure alignment with the industry standards and regulations.

Responsibilities

  • Launch Change Control Management
  • Manage externally sourced Biologics product launch change controls to ensure on time launch of new products for global regions.
  • Lead change control feasibility assessment launch to support project plan.
  • Initiate and manage change controls in support of externally sourced biologics product launches
  • Develop and manage launch execution plans.
  • In conjunction with cross functional team members develop change management plan in support of uninterrupted compliant supply of externally sourced biologics product.
  • Ensure standardization of launch change control process and execution efficiency.
  • Align with internal site change control processes

Education & Experience

  • Experience & exposure to quality systems such as Change Control, CAPA, TrackWise
  • An engineering or technical background
  • Experience of working across multi-functional teams
  • A Bachelor’s degree in Business, Supply Chain or equivalent.
  • 3 – 5 years of progressive experience in various Supply Chain, Contract Manufacturing Organisation (CMO) management, or Quality roles within the Pharmaceutical or Healthcare industries.

Desired:

  • Knowledge of compliance systems including software packages relating to supply chain management.
  • Knowledge of different aspects of regulatory compliance that impact a pharmaceutical supply chain.This can include but is not limited to GxP considerations and regulations.