Global Quality Systems Sr. Specialist (v852)

  • Contract Duration: 12 months, possibility to extend
  • Research & Development
  • Boston, MA

Website Lenox Executive Search

Description

Lenox Executive Search is looking to hire a Global Quality Systems Sr. Specialist for a contract position with one of our global pharmaceutical clients. This is a one-year contract with possibility of extension. GXP experience is a MUST!

The Global Quality Systems Sr. Specialist will work cross-functionally to support the needs of Global Vendor Quality System. This support includes execution of activities related to the design, oversight, and monitoring of the health of vendors and reporting metrics to the stakeholders across the operational areas including GxP Global disciplines, modalities (small molecule, cell/gene therapies, medical devices), technologies and countries/regions globally.

RESPONSIBILITIES of a Global Quality Systems Sr. Specialist:

Supports the day-to-day management of Vendor Quality Management System which includes the design, deployment, oversight, and monitoring of the health of vendors and KPIs. Key activities include:

  • Support management in developing and achieving strategic initiatives leading to the maturity of our Vendor Quality Management system to ensure sustainability, scalability, and efficiency of global quality systems for meeting emerging and future business needs across modalities (e.g., cell, gene, device, vectors), GxP areas, and geographies.
  • Serves as project coordinator / manager for Vendor Quality Systems projects and governance teams
  • Drives data consistency and accuracy in the Vendor Quality Management System
  • Generates Metrics / KPIs and develop Dashboards and Reports to support business
  • Drive cont. improvement in metrics related to vendor management by collaborating with both internal (all modalities) and external (vendors) stakeholders
  • Assists in the creation / maintenance of document and training materials
  • Communicates with team, stakeholders, and management on progress on goals and project deliverables
  • Completes assigned tasks independently with the ability to troubleshoot, make decisions and proactively communicates risks to ensure timely remediation

REQUIRED KNOWLEDGE and SKILLS, of a Global Quality Systems Sr. Specialist:

  • Basic regulatory compliance and quality management experience (across multiple GxP areas) preferred
  • Demonstrated experience in supporting the design, management, and improvement of global quality systems/processes
  • Project management knowledge and experience
  • Creative thinker complemented with change management experience, adaptability, resourcefulness
  • Strong communication, problem solving and critical thinking skills, accompanied by Analytical thinking/Data Analysis skills required to make sound decisions
  • Ability to work under minimal supervision
  • Ability to work and coordinate cross-functionally
  • Proficiency in using Microsoft Office applications
  • Experience with quality management applications such as Veeva

PREFERRED EDUCATION AND EXPERIENCE of a Global Quality Systems Sr. Specialist:

  • Bachelor’s Degree with a min of 2-5 years of relevant work experience
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