IT Governance, Risk & Compliance Specialist

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🔥 1 hour ago

☕ Washington – Remote

☕ Washington – Remote

💵 $100k - $135k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

💻 IT Support

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Altasciences

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1998

🧬 Biotechnology

💊 Pharmaceuticals

💰 Private Equity Round on 2017-06

Biotechnology • Pharmaceuticals

Altasciences is a forward-thinking, mid-size early phase contract research organization located in Canada and the U. S. , catering to biopharmaceutical companies of all sizes. The company specializes in offering a flexible approach to early drug development, with services that include preclinical safety testing, clinical pharmacology from Phase I to Phase II, bioanalysis from preclinical to Phase IV, as well as research and manufacturing analytical services. Altasciences is committed to accelerating early-phase drug development, ensuring seamless transitions from lead candidate selection to proof of concept and beyond, thereby delivering impactful results with a personal touch.

📋 Description

• 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.

🎯 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