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IT Compliance/Validation Lead

  • Anywhere

Company :
Hawkins Point Partners

Location :
Cambridge, Massachusetts

Expiry Date :
Mon, 14 Jun 2021 23:59:59 GMT

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Description :
Hawkins Point Partners is looking for IT Quality/Compliance Lead to join our Quality & Compliance team.

Person must be a mid- senior level able to independently drive tactical tasks to completion such as developing SOPs, working with business teams to review vendor documents and complete CSV deliverables. Flexible and able to scale approaches based on phase, risk and business needs. Analytical risk based decision maker able to solution and document decisions using technical writing skills.

Requirements

Experience developing IT SOPs, Forms for IT compliance, CSV, data management (transfer and exchange of data in clinical studies), data integrity, It security, CSV

Awareness and in depth knowledge of CSV (GxP), especially clinical.

Ability to work with business to complete new and retrospective System impact assessments.

Experience manage IT change controls

Updating and managing system inventory

Supported CSV projects as back up when needed

Supported inspection preparation

Knowledge of SOX, It security and infrastructure would be advantageous

Benefits

At Hawkins Point Partners we believe in creating great experiences for our colleagues. We offer competitive compensation along with comprehensive benefit options to meet the diverse needs of our colleagues in their personal and professional lives.