**Job Description:** **Experience Required:** 5–8 years **Domain Expertise:** Pharmaceutical industry, Pharmacovigilance, GxP compliance, Quality Assurance, Audit processes, 21 CFR Part 11, GDPR, and GAMP 5 Experienced in regulatory compliance and auditing, with a strong ability to design, implement, and enforce policies that meet all legal and organizational requirements. Adept at evaluating high‑risk areas to ensure rigorous internal and external compliance. Good Clinical Practice (GCP) **Key Responsibilities** + Lead Computer System Validation (CSV) activities in alignment with **GxP** , **21 CFR Part 11** , **GDPR** , and **GAMP 5** guidelines. + Develop, review, and approve validation documentation including protocols, reports, and risk assessments. + Ensure systems comply with regulatory expectations for electronic records, electronic signatures, and data privacy. + Apply **GAMP 5 principles** to validation lifecycle management, risk-based approaches, and system categorization. + Oversee QA processes to maintain compliance with industry standards, internal SOPs, and global data protection regulations. + Act as the primary point of contact during client and regulatory authority audits, demonstrating strong leadership and subject matter expertise. + Collaborate with cross-functional teams to identify gaps, implement corrective actions, and drive continuous improvement. + Provide training and guidance on CSV, QA, and regulatory compliance best practices. **Required Skills & Qualifications** + 5–8 years of professional experience in CSV and QA within the pharmaceutical domain. + Strong knowledge of **GxP regulations, 21 CFR Part 11, GDPR, GAMP 5** , and audit processes. + Proven track record of successfully leading client-facing audits and regulatory inspections. + Excellent written and verbal communication skills, with the ability to present complex information clearly. + Strong analytical, problem-solving, and organizational skills. + Ability to work independently and collaboratively in a fast-paced environment. **Preferred Attributes** + Experience in handling multiple projects simultaneously. + Strong stakeholder management and client engagement skills. + Demonstrated ability to influence and lead discussions with client and regulatory authorities. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us. EEO Minorities/Females/Protected Veterans/Disabled