Senior IT Quality/Infrastructure Consultant

Hawkins Point Partners Cambridge , MA 02138

Posted 2 days ago

Hawkins Point Partners is looking for IT Quality/Infrastructure Analyst to be part of the IT Quality team within the Corporate Quality. This person will be responsible for defining, planning, and performing duties that support major system development life cycle activities, including infrastructure qualification and change control approval of IT systems. In partnership with the team, support activities associated with implementation of a new Computerized Systems (CS) quality system delivering technically robust systems that withstand audits, both internal and external. Utilizes industry experience to partner and drive improvements. Requires strong Infrastructure IT Risk/Controls/Compliance Auditor level person. Someone who can apply periodic application reviews to the infrastructure side of the house. This person will provide guidance and address questions. Stack is Linux/Unix, on-prem and cloud. GxP/LS experience a HUGE plus, but a strong candidate from other regulated compliance environments (HIPAA, SOx, Dodd-Frank, etc.) would be considered.

Must have hands-on experience supporting implementation of computerized systems (i.e., IT, Manufacturing and QC) within a GxP environment.

Ability to complete tasks independently and with limited oversight.

Ability to interpret regulatory guidance (GxP) and policies and procedures into executable and defendable lifecycle documentation.

Depth of understanding of respective regulations governing computer systems and controls such as FDAs 21 CFR Part 11, EMAs Annex 11, and MHRAs data integrity guidance.

Understanding of modern and risk based validation executions.

Knowledge of underlying infrastructure requirements supporting GxP systems a plus.

Experience in remediating GxP Systems leveraging risk based methodologies

5+ years working in CSV or Quality role supporting computerized systems.

Background in Lifesciences and/or Pharma/Biotech industries

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.

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Senior IT Quality/Infrastructure Consultant

Hawkins Point Partners