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Senior Manager, GCP Compliance

Employer
Takeda
Location
Boston, Massachusetts
Start date
Jan 14, 2025
View more categoriesView less categories
Discipline
Regulatory, Legal/Compliance
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Genetown, Best Places to Work

Job Details

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

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.

For Location:

Boston, MA

U.S. Base Salary Range:

133,000.00 - 209,000.00

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-termincentives. 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.

LocationsBoston, MA

Worker TypeEmployee

Worker Sub-TypeRegular

Time TypeFull 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.

Company

For over 240 years, Takeda’s propensity to evolve has driven the next generation of innovation. Today, our organization spans the globe—colleagues across business units and functions face challenges head-on to deliver life-transforming treatments, guided by our commitment to patients, our people and the planet.

As a values-based, R&D-driven biopharmaceutical leader headquartered in Japan, we focus our R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. In addition to our R&D efforts, we’re laser-focused on harnessing the power of data, digital, and technology to improve health outcomes for patients across the globe.

 

Since our founding in Japan, integrity and putting patients first have been at the heart of our identity. We're proud of our employees and their commitment to improving the quality of life for patients, and to working with our partners in health care in approximately 80 countries and regions. With each new breakthrough comes opportunities to develop your career, hone new skills, and create a brighter future

For more information, visit https://jobs.takeda.com/

Company info
Website
Location
650 East Kendall Street
Cambridge
MA
02421
United States

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