GCP Compliance Manager – Novartis, Hyderabad (On-site)
Job Summary:
Novartis Healthcare Pvt. Ltd., a global leader in healthcare innovation, is seeking an experienced GCP Compliance Manager for its Hyderabad site. The role ensures effective GxP and GCP compliance across regulated Global Clinical Operations (GCO) activities. The ideal candidate will bring deep knowledge of clinical research standards, regulatory compliance, risk management, and inspection readiness. This position offers an excellent opportunity to influence quality culture and regulatory excellence within one of the world’s top pharmaceutical companies.
Key Responsibilities:
Ensure oversight and control of GCO-wide regulated activities impacting project delivery.
Provide GxP compliance expertise to functional teams and cross-functional risk groups.
Manage systemic quality issues, deviations, and quality events to ensure regulatory alignment.
Coordinate and lead system/process audits and global inspections to support regulatory authorizations.
Deliver self-assessment strategies, controls, and risk assessments within GCO.
Monitor performance indicators and detect potential risks or trends at the GCO level.
Foster a culture of compliance, integrity, and quality across the GCO division.
Collaborate with cross-functional stakeholders, Quality Assurance, and global compliance teams.
Required Skills & Qualifications:
Education: Advanced degree in Science, Engineering, or related field.
Experience: 8+ years in clinical operations or clinical research with strong regulatory knowledge.
Strong expertise in GCP, GxP compliance, audits, inspections, and quality management systems.
Proficiency in risk management, RCA, CAPA development, and inspection readiness.
Exceptional analytical, organizational, and critical-thinking skills.
Strong communication and stakeholder management abilities.
Ability to work independently within a global matrix environment.
Fluent in English (spoken and written).
Perks & Benefits:
Competitive salary and comprehensive benefits package.
Access to Novartis professional growth and learning platforms.
Inclusive, diverse, and collaborative work culture.
Opportunities to influence global pharmaceutical quality and compliance standards.
Health, wellness, and personal development programs.
Company Description:
Novartis Healthcare Pvt. Ltd. is a world-renowned pharmaceutical leader, focused on delivering innovative medicines that transform patient outcomes. With a strong presence in global markets, Novartis drives cutting-edge research and sets high standards in drug development, clinical trials, and healthcare compliance.
Work Mode:
On-site (Hyderabad, India)
Call-to-Action:
Are you ready to shape global pharmaceutical compliance and ensure excellence in clinical research? Apply now to become a part of Novartis’ impactful healthcare journey as a GCP Compliance Manager in Hyderabad.
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