Associate Director – GCP Compliance | Takeda | Bengaluru, Karnataka
Job ID: R0151446
Location: Bengaluru, India
Job Type: Full-time | Regular | Senior Level
Travel: Minimal
Salary:
Estimated Range: ₹60 – ₹80 LPA
(Based on seniority, GCP expertise, and global compliance responsibilities in the pharmaceutical sector)
Role Overview:
Takeda is seeking an experienced Associate Director – GCP Compliance to lead and strengthen regional Good Clinical Practice (GCP) compliance activities. The role plays a critical part in proactively assessing risk, enhancing audit readiness, improving inspection strategies, and ensuring compliance across clinical trial delivery in the APAC region.
Key Responsibilities:
1. GCP Compliance Management:
Oversee quality events including deviation analysis, CAPA implementation, and non-compliance reporting
Manage internal audits, support study teams during audits, and partner with Quality Assurance for audit scopes
Drive risk-based compliance assessments to embed proactive inspection readiness in clinical operations
Serve as TMF process expert, supporting regulatory inspections as needed
2. Inspection Readiness & Risk Mitigation:
Collaborate with R&D Quality and GCP teams on inspection strategies aligned with global regulatory submissions
Participate in GCP excellence initiatives to strengthen process adherence and team preparedness
Build and lead mitigation strategies for project-level risks and region-specific challenges
3. Metrics & Reporting:
Develop and report on KPIs, dashboards, and analytics to track GCP compliance performance
Interface with global stakeholders and provide strategic reporting for continuous improvement
4. Strategic Leadership & Training:
Lead cross-functional clinical trial teams on GCP compliance awareness and implementation
Mentor and coach direct/indirect reports, fostering a culture of accountability and innovation
Serve as a role model for Takeda’s values, especially around integrity, inclusion, and ethics
Qualifications & Experience:
Bachelor’s degree (Life Sciences preferred); international equivalent accepted
8+ years in pharma/CROs, with at least 6 years in GCP compliance or clinical study operations
Prior experience leading audits, inspections, and global compliance initiatives
Strong strategic mindset, cross-functional leadership, and operational acumen
Deep knowledge of global GCP regulations and clinical development workflows
Experience in managing global clinical trials and collaborating across geographies
Skills & Competencies:
Excellent communication and stakeholder management across functions
Effective in navigating complex regulatory environments
High capability in decision-making, problem-solving, and change management
Proficient in leveraging digital collaboration and reporting tools
Why Join Takeda:
Join a 240-year legacy of translating science into life-changing medicines. At Takeda, you’ll drive critical GCP compliance strategies, shape future-ready inspection practices, and collaborate across global teams—all in an inclusive, innovation-led culture.
📘 Explore Takeda’s People & Culture
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