SalaryUSD TBD TBD
- Bachelor's degree required, preferably in Business, Engineering or Computer Science or related field required. Masters degree in Business or Engineering preferred.
- At least Eight years experience within a business function (Quality, Manufacturing, or Engineering) with business analysis, business process improvement, Software Quality Assurance and Validation activity required.
- Must have thorough understanding of 21 CFR 820 and Part 11, cGMP regulations and software validation guidance and/or requirements.
- Previous position in Pharma or Medical Device industry.
- Experience with GAMP 5 and DevOps Frameworks.
- Experience with process improvement techniques and tools. Lean or Six Sigma preferred.
- Strong communication (written and oral) and presentation skills.
- Ability to work comfortably at all levels within the organization up to the senior management level.