Systems Technology Compliance Senior Specialist
Location: India (2nd Shift Hours, 2 PM–11 PM IST)
Work Mode: On-site
Experience Level: Mid-level (Minimum 4 years)
Job Type: Full-time
Salary/Compensation: Not specified (industry standard)
Job Summary
Fortrea, a global leader in clinical development and regulatory compliance, is hiring a Systems Technology Compliance Senior Specialist. This role is critical in auditing, advising, and ensuring adherence to computerized systems regulations across GxP domains. Ideal for professionals experienced in regulatory environments, this role offers the opportunity to contribute to drug development through technology and compliance excellence.
Key Responsibilities
Audit System Life Cycle (SLC) activities and ensure documentation compliance
Plan and conduct internal and external audits (vendors/suppliers)
Participate in client and regulatory visits as a subject matter expert
Develop and review SOPs, policies, and other controlled documentation
Guide business, IT, and QA teams on compliance requirements
Lead or support process improvement projects and continuous improvement
Ensure compliance with QA and Regulatory standards per SOPs
Maintain up-to-date training in accordance with departmental requirements
Perform other duties as assigned by management
Required Skills & Qualifications
Bachelor's degree in Life Sciences preferred (or equivalent relevant experience)
Minimum 4 years in a regulatory/compliance environment, specifically with system compliance
Strong understanding of computer system development life cycles
Knowledge of GxP regulations and computerized systems standards
Experience applying compliance in drug development settings
Excellent verbal and written communication skills
Capable of engaging with regulatory bodies and clients
Strong analytical and negotiation skills
Ability to deliver training effectively
Willingness to work second shift hours (2 PM – 11 PM IST)
Ability to occasionally work overtime or weekends
Regional travel up to 5%
Perks & Benefits
Work with a globally recognized CRO with operations in 100+ countries
Engage in impactful regulatory and compliance work across therapeutic areas
Supportive culture of innovation and continuous improvement
Exposure to cutting-edge technology systems in life sciences
Opportunities for career growth within regulatory and QA domains
Work in a diverse, collaborative, and mission-driven environment
Company Description
Fortrea is a leading global Contract Research Organization (CRO) delivering advanced clinical development and technology solutions across 20+ therapeutic areas. With deep scientific expertise and regulatory excellence, Fortrea transforms drug and device development to accelerate patient access to life-changing therapies.
Work Mode
On-site
Shift: 2 PM – 11 PM IST (Second Shift)
Call to Action
Are you ready to elevate compliance and quality standards in the global pharma industry?
Apply today and become part of Fortrea’s mission to advance healthcare through innovation and regulatory excellence.
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