Job Summary
A biotechnology company has an open position for a Senior Computer Systems Compliance Specialist.
Core Responsibilities of this position include:
- Approving regulatory required documentation and ensure compliance
- Interfacing with global partners and site leadership regarding quality issues
- Communicating actions, compliance gaps, and commitments to respective areas
Must meet the following requirements for consideration:
- Up to 25% domestic and/or international travel may be required
- Bachelor’s Degree or higher in Science, Engineering or QA/Regulatory related course of study
- Minimum of 7 years experience in a regulated industry with direct pharmaceutical experience in QA, QC or Regulatory Affairs
- Experience with GxP computer system regulations and GAMP 5