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Manager Digital Systems Compliance



Cambridge, MA, USA
Posted on Friday, May 26, 2023

We are seeking an experienced Manager of Digital Systems Complicance for our Digital, Data & Informatics team!

Responsibilities include:

Defining validation strategy and validation activities of Clinical Development systems and solutions

Create Validation Lifecycle documents (e.g., change, validation plan, reports, …) and records according to standard operating procedures, regulatory requirements, and guidelines; ensures timely resolution of documentation, compliance, and Clinical Development system issues

Supports independent continuous improvement of validation documentation and processes and supports implementation of improvements

Acts as the contact person for all validation issues, together with the relevant process, validation and system owners, project management and SMEs; supports the audit process Oversee the Clinical systems change control process and implementation of change control plan

Requirements include:

Bachelor's degree in Information Systems, Medical, Pharmaceutical or Biomedical sciences AND at least 5 years’ experience in validation / quality, ideally in the pharmaceutical and biotech industry

Knowledge in computer system lifecycle activities, CSV / CSA and IT controls in a regulated environment

Well versed with CSV/CSA regulations like 21 CFR 11, Annex 11, EMA and ICH Guidelines, CSA Guidance etc.

Knowledge of IT Control methodologies, including a solid understanding of GxP guidance

IT knowledge (access control, account setup, file permission, database knowledge, cloud knowledge)