Associate Director, Clinical Quality Compliance

Job Title : Associate Director, Clinical Quality Compliance

Location : Cambridge, MA

About the role :

As the Associate Director, Clinical Quality Compliance, you will oversee the quality systems supporting clinical trial delivery, ensuring operational excellence, compliance, risk management, and knowledge sharing. You will implement monitoring systems to maintain regulatory alignment and advise the Head of GCP Quality Compliance on strategy, operational management, and capability building within the GCP Compliance team.

How You Will Contribute :

Collaborate with various functions involved in clinical trial delivery to identify risks, conduct investigations, and develop corrective and preventive actions (CAPAs). Manage change processes and drive improvements aligned with Takeda's values and priorities.

• Lead the clinical trial system inspection readiness program, developing strategies and engaging relevant partners such as Global Development Office, Data Science Institute, Global Regulatory Affairs, Procurement, and Legal to ensure preparedness and transparency.
• Provide insights into regulatory requirements, operational metrics, and inspection risks; develop mitigation strategies.
• Host GCP inspections and provide strategic guidance to responsible teams and SMEs.
• Maintain a communication plan for sharing inspection insights, risks, and progress, escalating issues promptly.
• Manage inspection responses, ensuring they are thorough, approved, and submitted timely, with appropriate root cause analysis and CAPA development.
• Oversee the closure of CAPAs, ensuring effectiveness and timely completion, escalating risks as needed.
• Serve as SME for Clinical Quality Compliance activities including deviation management, investigations, CAPA oversight, and change control, representing these topics during inspections.
• Support other inspection types (e.g., GVP, GMP) with guidance.
• Lead complex quality investigations, providing leadership and ensuring impact assessments and root cause analyses are thorough.
• Develop lessons learned from inspections and investigations to promote knowledge sharing.
• Drive quality improvement projects to maintain compliant clinical trial systems.
• Approve controlled procedures related to clinical trial quality systems, ensuring regulatory and inspection commitments are met.
• Escalate critical non-compliance issues to senior management and analyze trends to promote ongoing compliance.
• Develop and monitor relevant metrics and KPIs/KQIs, communicating risks and ensuring timely actions.
• Contribute to governance activities, including the Clinical & Safety Quality Council, by reporting on quality and compliance risks, opportunities, and improvements.

What you bring to Takeda :

BSc in a scientific or health-related field (or equivalent).

• Minimum 10 years of increasing responsibility in the pharmaceutical industry, including at least 5 years in GCP Quality/Compliance, with experience in Clinical Operations, Data Management, or Statistics.
• Knowledge of pharmaceutical development, GCP/GVP regulations (FDA, EU, MHRA, PMDA, ICH).
• Experience with audit programs, regulatory inspections, and remediation at a global level.
• Proven ability to manage compliance issues and lead organization-wide compliance initiatives.

Additional considerations :

• May require PPE and work in controlled environments, including handling chemicals, working in cold/wet conditions, or working multiple shifts.

More about us :

Takeda is dedicated to transforming patient care through innovative pharmaceuticals and support programs. We foster an inclusive, collaborative workplace committed to excellence and better health outcomes globally.

We are a Certified Global Top Employer, offering stimulating careers, encouraging innovation, and promoting a culture of continuous improvement.

GMSGQ #ZR1 #LI-MA1

Takeda Compensation and Benefits Summary

We value equitable pay and transparency. The U.S. salary range for this role is $149,100 - $234,300, subject to individual qualifications, experience, skills, education, certifications, and location.

Eligible employees may participate in incentive plans, health insurance, 401(k), disability, life insurance, tuition reimbursement, paid time off, holidays, and well-being programs. Sick leave and paid vacation are also provided.

EEO Statement

Locations

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time