Takeda · 9 hours ago
Senior Manager Clinical Program Quality
United States
Full-time
Remote
Senior Level
$137K/yr - $215K/yr
7+ years expTakeda is focused on creating better health for people and a brighter future for the world. The Senior Manager Clinical Program Quality will oversee quality assurance for global clinical research, acting as a strategic quality advisor and guiding risk-based decisions in research quality.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
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
Qualification
Required
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
Benefits
Medical, dental, vision insurance
A 401(k) plan and company match
Short-term and long-term disability coverage
Basic life insurance
A tuition reimbursement program
Paid volunteer time off
Company holidays
Well-being benefits
Up to 80 hours of sick time
Up to 120 hours of paid vacation
Company
Takeda
Takeda is a biopharmaceutical company that researches and develops pharmaceutical drugs.
10001+ employees
H1B Sponsorship
Takeda has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (39)
2023 (38)
2022 (34)
2021 (44)
2020 (18)
Funding
Current Stage
Public CompanyTotal Funding
$2.46B2025-06-27Post Ipo Debt· $2.4B
2016-09-01Grant· $19.8M
2016-05-08Grant· $38M
Leadership Team
Christophe Weber
President and CEO
Schuyler Fairfield
Senior Vice President, Global Head of Supply Chain
Recent News
2026-01-25
legacy.thefly.com
2026-01-23
2026-01-22
Company data provided by crunchbase