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Job Description

About the role:

As the Senior Quality Complaints Specialist, you will ensure the quality of processes and product outputs by defining activities, processes, and standards. Your role will involve auditing, monitoring, and determining the quality of processes or outputs to meet internal and regulatory standards. You will support Takeda's mission by ensuring product integrity and compliance with quality requirements. You will report to the Complaints Lead.

How you will contribute:

• Define and specify activities, processes, and standards to meet quality requirements
• Audit, monitor, and determine the quality of processes or outputs
• Conduct product integrity testing to ensure compliance with quality requirements
• Report on process deviations and defects
• Manage projects and processes independently
• Coach and review the work of lower-level professionals

Minimum Requirements/Qualifications:

• Bachelor's degree with a minimum of 5‐9 years of experience in Quality Assurance or a GMP related field within biotechnology or pharmaceutical manufacturing, or equivalent
• Working knowledge of cGMPs and other regulatory requirements governing combination drugs and device products
• Knowledge of EU/ FDA cGMP requirements of drug/device product complaints reporting and investigation
• Desirable experiences: combination working experiences in product complaints handling, deviation management, CAPAs, quality compliance investigations, risk management, and cGMP audits
• Experience with the manufacturing of combination products and the linkage to customer complaints
• Have a systematic way of working, prioritizing tasks based on risk or criticality ‐ looking for solutions within the complexity that surrounds product complaints.
• Excellent troubleshooting and problem‐solving skills
• Skill in writing investigation summaries or reports and complaint responses.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.

#LI-Hybrid

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. 

For Location:

Lexington, MA

U.S. Base Salary Range:

$86,500.00 - $135,960.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/