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Global R&D Operations Manager

Company: Estee Lauder
Location: Melville
Posted on: June 12, 2021

Job Description:

The primary role of this position is to ensure R&D business processes are effective and efficient. This position requires analysis of business processes - identifying gaps and formulating remediation options - that will warrant robust processes governed by SOPs/ WKIs with clear roles and responsibilities.

The scope includes

  • Leading the Process Analysis, Process Documentation and SOP adherence across R&D.
  • Managing governance of processes, access, SOPs and documentation to ensure compliance.
  • Co-ordinating with the R&D Sites to ensure robust operationalization & Implementation of DI policies, standards and guidelines.

The geographic scope is Global and includes all R&D Sites - Melville (USA), Blaine (USA), Shanghai (China), Toronto (Canada), Paris (France), Seoul (South Korea) and Tokyo (Japan).

  • Lead analysis of new and existing R&D processes for effectiveness and efficiency
  • Analyze and document business processes.
  • Work closely with stakeholders to identify process gaps and remediation options.
  • Recommend future state/end state processes.
  • Provide guidance on SOP/WKI templates and training to impacted departments to ensure their functional subject matter experts (SMEs) can create the required documentation.
  • Accurate record keeping for all R&D SOPs on respective documentation management system (OpenText, Sharepoint)
  • Accurate record keeping for all training and training documentation on their respective learning management system (ELC learning center e.g. SumTotal, Sharepoint)

  • Collaborating with Corporate functions - Global Supply Chain, Global QA and IT - to ensure SOP and Work Instruction standards are aligned cross functionally.
  • Coordinate with IT for the execution of required remediations and/or enhancements.
  • Provide management updates (monthly/quarterly) at Global and Site level to ensure visibility of process priorities and risks.
  • Ensures adherence to FDA Validation, CFR 21 Part 11 and Change Control management processes requiring a detail knowledge of the R&D Quality Systems inclusive of Change Control , CAPAs and Deviation procedures.
  • Experience in analyzing business processes for compliance, effectiveness and efficiency.
  • Experience in writing GxP process documentation, SOPs and training.
  • Strong communication skills for effective stakeholder engagement and consensus building.
  • Experience in project management a plus.
  • Experience in Electronic Document Management Systems (e.g. OpenText) preferred
  • Knowledge of GXP (Good Clinical/Manufacturing/Documentation practices)

Knowledge of FDA Validation and CFR 21 Part 11

College Graduate - BS

5 Years Experience

5% Travel

Keywords: Estee Lauder, New Haven , Global R&D Operations Manager, Other , Melville, Connecticut

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