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Global-Category-Associate-Director-Hyderabad

4+ years
Not Disclosed
10 July 31, 2025
Job Description
Job Type: Remote Education: B.Sc./M.Sc/B.harm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

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.