CambridgeRecruiter Since 2001
the smart solution for Cambridge jobs

IT Compliance Lead

Company: Vericel Corporation
Location: Cambridge
Posted on: November 23, 2022

Job Description:

If you start your application and need to come back to it, please click on the 'Forgot your password?' link to retrieve your profile information in order to get back into your application.POSITION SUMMARY
Accountable for delivering validation knowledge leadership for IT projects by creating computerized systems life cycle documentation, creating and revising IT standard operating procedures and deploying technology solutions to ease the administrative burden in a compliant manner.ESSENTIAL FUNCTIONS

  • Develop solutions (knowledge base, artifacts, technology) to address IT Quality Compliance needs.
  • Deliver agility to the organization by streamlining IT Change Management and CSV processes.
  • Draft Computer Systems Validation and IT Change Management SOPs to align with GAMP 5 and industry standards.
  • Author, review and update validation documents as necessary for GxP IT implementation projects.
  • Provide Delivery Support to multiple ongoing IT initiatives.
  • Evaluate business requirements and provide solutions based on need.
  • Provide expertise in the areas of IT Quality & Compliance, Computer Systems Validation, Quality assessments, ISO 13485 regulations, 21 CFR Part 11, Annex 11, GxP requirements, Quality System Regulations, CAPA processes, Quality Management Systems design, Supply chain management, process validation and Quality system validation for regulated Life Science environments.QUALIFICATIONS, EDUCATION AND EXPERIENCEBasic Qualifications:
    • MUST have Pharmaceutical, Bio-Technology, or Life Science industry experience
    • 7+ years of experience in Computer System Validation in a cGMP manufacturing environment.
    • Knowledge of GMPs, GAMP 5, 21 CFR Part 11, Annex 11, MHRA/FDA Data Integrity

Keywords: Vericel Corporation, Cambridge , IT Compliance Lead, Other , Cambridge, Massachusetts

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Log In or Create An Account

Get the latest Massachusetts jobs by following @recnetMA on Twitter!

Cambridge RSS job feeds