Azzur Group
  • NY, USA
  • Full Time

Full benefits plus bonus


We are seeking talented professionals for exciting Director level openings at a Life Science leader, to help lead a renewed IT Quality Department including compliance and infrastructure qualification programs, in support of a variety of regulatory and IT processes.    Great opportunity to join talented team with state of-the-art technologies  offering engaging work environment and attractive compensation/benefits. Successful candidates will provide leadership and develop and implement processes and programs in support of regulatory and IT client needs.  Duties include:

  • Develops, owns and administers processes related to Infrastructure Qualification, Risk and Change Management, CAPA and others related to the IT/Quality function.
  • Oversees and tracks programs and activities, works closely with functional groups and documents/reports on key performance indicators and risks/mitigations.
  • Manages staff and resources  to develop, establish and maintain a high functioning and quality-focused team in support of the company IT and Quality objectives.

Qualifications

  • Bachelor's Degree and at least 10 years experience in an IT Compliance/Quality role in a FDA or related regulatory environment.
  • Strong knowledge and understanding of IT infrastructure qualification, risk assessment, change/configuration management, and related processes.
  • In-depth knowledge of pharmaceutical cGMPs, SOX, EMA, Part11, IT best practices, FDA Guidance.
  • Experience managing/ leading others and the ability to effectively work with diverse technical and professional staff and stakeholders.
  • Effective interpersonal, communication, organizational and analytical skills to resolve challenging issues, manage multiple priorities and facilitate task and project completion.  
  • Proficiency with MS Office software including MS Word, Excel and Powerpoint.
Azzur Group
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