Senior Manager Clinical Program Quality

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Job Description

Are you looking for a patient-oriented, innovation-driven role that inspires you and promotes your career? Then take your future in your hands and become part of our team as a

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.

How you will contribute:

• 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.

In this position you will report to the Head of Clinical Program Quality, Gastrointestinal and Inflammation.

What you bring to Takeda:

• 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.

About Us:

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience, and vaccines.

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and the best patient support programs. Takeda is a patient-focused company to 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.

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:

Massachusetts - Virtual

U.S. Base Salary Range:

$137,000.00 - $215,270.00

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/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. 

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in 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, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. 

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Massachusetts - Virtual

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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