ROLE SUMMARY
The Compliance & Validation Advisor ensures engineering practices align with regulatory expectations, particularly for auditability, traceability, and documentation.
This role is essential for enterprise trust.
ENGAGEMENT MODEL
- Advisory role
- Engaged during design and pre-release phases
KEY RESPONSIBILITIES
Validation Framework
- Define validation approach aligned to regulated industries
- Review validation documentation and evidence
- Ensure traceability across requirements, design, and testing
Audit Readiness
- Prepare engineering teams for audits
- Review SOPs and records
- Support customer audits as needed
REQUIRED QUALIFICATIONS
- 10+ years in validation/compliance roles
- Experience with regulated software systems
- Ability to translate regulatory language into engineering actions
ASSESSMENT PARAMETERS
- Regulatory fluency
- Practical implementation guidance
- Documentation quality
- Credibility with auditors
