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Job Description

Job Title: Senior Manager, GCP Compliance

Location: Cambridge, MA

About the role:

As a Senior Manager, GCP Compliance, you will provide quality oversight to clinical trial delivery quality systems, promoting operational and compliance excellence, quality risk management, and knowledge management. It involves partnering with various functions involved in clinical trial delivery to identify and investigate quality and compliance risks, conduct investigations, and develop corrective and preventive actions (CAPAs). You will also manage changes and facilitate continuous improvement aligned with Takeda’s values and priorities. Reporting to the Head of Clinical Quality Compliance, you will contribute to the development and implementation of Clinical Quality Compliance strategy and vision.

How you will contribute:

• Contribute to the clinical trial delivery system inspection readiness program, ensuring accountability and transparency across various functions.

• Review emerging regulations, operational and compliance metrics, and identify quality and compliance inspection risks, providing proactive mitigation directions.

• Support GCP inspections and provide guidance to relevant functions and Subject Matter Experts (SMEs).

• Develop a robust communication plan, sharing relevant information, insights, and risks, and escalate issues to management.

• Support inspection response activities, ensuring responses are adequate, reviewed, approved, and submitted on time.

• Oversee the completion and closure of inspection CAPAs, ensuring timely effectiveness checks and mitigating risks.

• Provide guidance for non-GCP inspections (e.g., GVP, GMP).

• Lead quality investigations impacting clinical trial delivery systems, engaging the right stakeholders in root cause analysis and CAPA development.

• Promote knowledge management through lessons learned from regulatory inspections and quality investigations.

• Participate in cross-functional continual improvement projects to maintain compliant clinical trial delivery quality systems and escalates critical non-compliance issues to senior management.

What you bring to Takeda:

• BSc in a scientific or allied health/medical field (or equivalent degree).

• Minimum of 5 years of increasing responsibility and relevant experience in the global pharmaceutical industry in functions such as Clinical Operations, Data Management and Statistics, with at least 2 years of experience in GCP Quality/Compliance.

• Experience must include successful development and implementation of a clinical or pharmacovigilance audit program, hosting/leading regulatory inspections and remediation activities on a global level.

• Advanced knowledge of pharmaceutical development, medical affairs and  GCP/GVP regulations including FDA, EU, MHRA, PMDA and ICH.  

• Experience managing complex global, cross-functional organizational compliance issues and in identifying and implementing organization-wide compliance initiatives.

• Fluency in written and spoken English, additional language skills a plus.

Important Considerations

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:

• May be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.

• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.

• Work in a cold, wet environment.

• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.

• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

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.

#GMSGQ  #ZR1  #LI-MA1

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.

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U.S. Base Salary Range:

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.

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Job Exempt