Quicker go/no-go decisions with integrated preclinical, clinical, bioanalytical, manufacturing, and CRO services.
IT Governance, Risk & Compliance Specialist
Location
Washington
Posted
7 days ago
Salary
$100K - $135K / year
Seniority
Senior
Job Description
IT Governance, Risk & Compliance Specialist
Altasciences
• Support internal audits, client audits, and regulatory inspections, ensuring documentation and evidence are inspection-ready. • Track audit observations, CAPAs, and remediation activities through completion. • Support computerized system compliance activities, including validation documentation reviews, change controls, and periodic reviews. • Manage the qualification and ongoing assessment of IT vendors and technology service providers. • Conduct risk-based assessments of vendors, cloud solutions, and emerging technologies. • Author, maintain, and improve IT SOPs, standards, and compliance documentation. • Participate in privacy impact assessments and AI governance reviews. • Monitor regulatory trends and industry best practices related to GxP, privacy, cybersecurity, and IT compliance. • Develop compliance metrics and contribute to continuous improvement initiatives across the IT organization.
Job Requirements
- College diploma or degree in Information Technology, Computer Science, Quality Assurance, or a related field.
- Minimum 5 years of experience in IT, compliance, quality, validation, privacy, cybersecurity, or a related discipline.
- Knowledge of GxP regulations and computerized systems compliance, including FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
- Experience supporting audits, inspections, CAPA management, or quality systems.
- Familiarity with vendor qualification, risk assessments, and third-party risk management practices.
- Understanding of privacy regulations such as Law 25, PIPEDA, and GDPR.
- Strong written and verbal communication skills with the ability to work effectively across technical and business teams.
- Excellent organizational, analytical, and problem-solving skills.
- Experience in the pharmaceutical, biotechnology, CRO, or other regulated industry is considered an asset.
- ITIL, CSV, GxP, ISO 27001, SOC 2, or related certifications are considered assets.
Benefits
- Health/Dental/Vision Insurance Plans
- 401(k)/RRSP with Employer Match
- Paid Vacation and Holidays
- Paid Sick and Bereavement Leave
- Employee Assistance & Telehealth Programs
- Telework when applicable.
- Training & Development Programs
- Employee Referral Bonus Program
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