Senior Manager Clinical Program Quality

Role Summary

Senior Manager Clinical Program Quality: You will oversee quality assurance for global clinical research across multiple business units, focusing on continuous inspection readiness. This role acts as a strategic quality advisor, partnering with clinical teams and stakeholders to guide risk-based decisions in research quality.

Responsibilities

• Provide expert GCP compliance guidance, training, and recommendations to program teams and leadership.
• Develop, implement, and manage risk-based audit strategies and conduct complex audits in line with GCP and Takeda policies.
• Assess and escalate compliance risks impacting subject safety, data integrity, or business operations to management.
• Ensure completion of timely audit reports and corrective actions, tracking effectiveness and regulatory reporting as needed.
• Lead investigations into significant quality issues and GCP breaches, ensuring root cause analysis and effective corrective actions.
• Support and manage GCP health authority inspections, guiding teams in preparation, response, and follow-up activities.
• Collaborate with Quality teams to identify, analyze, and address GCP compliance issues and present key metrics and recommendations to management.

Qualifications

• Bachelor’s degree required; advanced degree preferred.
• At least 7 years of experience in pharma, biotech, or related healthcare industries.
• Minimum 5 years in GCP Quality Assurance or relevant clinical trial roles.
• In-depth knowledge of ICH GCP R2 and global clinical regulations.
• Advanced auditing expertise, including translating findings into risk-mitigating action plans.
• Excellent communication, technical writing, negotiation, and teamwork skills.
• Strong analytical abilities, sound judgment, and effective project management under tight timelines.