About this role
Role Overview
- Provide support for standardized digital quality systems programs
- Evaluate existing digital quality systems worldwide
- Perform training of key personnel to global policies
- Participate in activities for global inspection preparedness, audit response and CAPA related to digital quality systems
- Review and/or approve system validation documentation
Requirements
- Minimum of a Bachelor's degree (or equivalent) in a science-related discipline
- Minimum of 6 years of directly relevant experience
- Minimum of 10 years of relevant experience in Quality and/or Regulatory Affairs, or 8 years with a Master’s degree
- Sound knowledge of cGMP regulations
- Familiar with Global Systems concepts
- Ability to review, interpret, and discuss governing regulations
- Strong computer skills, working knowledge of Microsoft Office
Benefits
- Competitive salaries
- Health insurance
- Retirement plans
- Paid time off
- Professional development opportunities