About The Position

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Director, Quality Vendor and Digital Data - REMOTE. In this role, you will be pivotal in ensuring that the standards of quality are met across various vendors and operations within our global framework. You will lead initiatives that aim to exceed the quality expectations set forth by both regulatory authorities and our key stakeholders. Your expertise will be crucial in creating an environment that prioritizes continuous improvement in compliance and operational practices. Join a diverse team of professionals dedicated to making a difference in the clinical research landscape while cultivating a culture of innovation and excellence.

Requirements

  • Demonstrated organizational leadership competencies and ability to lead a team effectively.
  • Advanced understanding of clinical research principles and processes for clinical trials.
  • Proven ability to drive results and collaborate cross-functionally.
  • Experience with identifying and implementing regulatory changes within life sciences.
  • Previous experience with leading or participating in Regulatory Authority Inspections.

Responsibilities

  • Responsible for a risk-based Quality Vendor Oversight Program to ensure quality of deliverables and compliance to GxP regulations.
  • Establish GCP Vendor quality agreements and GMP quality technical agreements with key external customers.
  • Oversee the management of the QVD Audit Plan inclusive of vendors, depots, CSV, vendor, system, GMP and GDP audits/CAPAs.
  • Serve as a GCP/GxP subject matter expert for GMP, GDP, and GCP related services as applicable to Vendors and Systems.
  • Lead, mentor, and inspire a global team, fostering a collaborative and innovative environment.

Benefits

  • Opportunity to contribute to impactful work improving lives.
  • Collaborative and inclusive work environment.
  • Commitment to professional development and growth.
  • Support for a diverse range of talents and experiences.
  • Work remotely with flexibility tailored to your schedule.
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