Related skills
gxp csv 21 cfr part 11 eu annex 11 regulatory compliance📋 Description
- Lead QA Systems to validate, document, and maintain system compliance.
- Oversee risk-based Computer System Validation per CFR Part 11, EU Annex 11, ICH E6.
- Collaborate with Security, Development, PMO, BRM, and DevOps to embed quality in SDLC/DevOps.
- Serve as primary liaison with regulators and third parties for audits/inspections.
- Ensure documentation is inspection-ready; train on validation and data integrity.
- Establish QA policies; monitor compliance trends; drive improvements.
🎯 Requirements
- 10 years of clinical research experience focused on QA/Compliance.
- Strong knowledge of Computerized Systems Validation (CSV).
- CSV experience in a GxP environment.
- Knowledge of ICH, 21 CFR Part 11, EU Annex 11, OECD guidelines.
- Supervisory/management experience leading QA personnel.
- Leadership in QA teams and cross-functional projects.
- Excellent communication, problem-solving, and organization.
- Bachelor's degree in science, healthcare, or related field.
- Availability to travel up to 25% domestically and internationally.
- Experience hosting audits.
🎁 Benefits
- Discretionary annual bonus
- Health insurance
- Retirement benefits
- Life insurance
- Disability benefits
- Parental leave
- Paid time off for sick leave and vacation
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