Demo

Associate Director, GCP Compliance

Takeda Pharmaceuticals
Honolulu, HI Full Time
POSTED ON 1/24/2025
AVAILABLE BEFORE 4/21/2025

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’s Privacy Notice and 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

Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as an Associate Director, GCP Compliance based remotely reporting to the Director, GCP Compliance.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.

Here, you will be a necessary contributor to our inspiring, bold mission.

GOALS :

  • Direct and drive the implementation of compliance management related to quality events and internal audits for clinical trial delivery functions including the identification and development of applicable processes and tools.
  • Establish and lead proactive risk-based compliance assessments for clinical trial delivery functions and ensure completion of robust CAPA / EC-related compliance assessments.
  • Develop and report to leadership on key performance indicators and mitigation strategies for clinical trial delivery.

ACCOUNTABILITIES :

  • Compliance Management
  • Oversee and manage quality events / deviations including root cause analysis, CAPA development and implementation, effectiveness check tracking, and non-compliance reporting.
  • Facilitate clinical trial delivery internal audits with study teams and functional areas including but not limited to : study team preparation, facilitating audit requests, managing audit responses and CAPA development and implementation. Partner with Quality Assurance to ensure appropriate audit scopes and clinical trial delivery participation.
  • Lead clinical trial functional areas and study teams on issues related to GCP compliance and liaise with study execution teams on compliance to clinical trial delivery procedures and developing effective mitigation and escalation strategies.
  • Compliance Assessments
  • Proactively identify process / therapeutic area / project risks and develop / lead assessments to assess compliance.
  • Advise process owners and functional areas on the development and implementation of effective mitigation and escalation strategies for projects to address risks and issues.
  • Develop, lead and oversee compliance assessments to address GCP Quality Plan, CAPAs / ECs and liaise with QA to ensure adherence to the plan.
  • GCP Compliance Metrics and Reporting
  • Engage and build relationships with clinical trial delivery functions, R&D QA, and other stakeholders on performance metrics, analytics and reporting for GCP compliance activities.
  • Identify, develop, and track KPIs, metrics and dashboards to track process quality and compliance.
  • Other

  • Responsible for training, coaching and mentoring supervised employees (direct and indirect reports) to create a culture that attracts, retains and develops innovative thinkers.
  • Act as role model for Takeda’s values.
  • EDUCATION AND EXPERIENCE :

  • Bachelor’s Degree or international equivalent required; Life Sciences preferred.
  • 8 or more years' experience in the pharmaceutical industry and / or clinical research organization, including 6 or more years in compliance or clinical study management required.
  • Global / international experience required, including ability to collaborate with colleagues and staff in other locations.
  • Experience in leading projects and coordinating collaboration with cross-functional teams.
  • Strong strategic thinking, planning, execution, and communication skills.
  • Operational experience in clinical development with significant direct exposure to implementation of novel approaches in clinical development.
  • Health care business acumen with a comprehensive understanding of the pharmaceutical industry.
  • 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 :

    149,100.00 - 234,300.00

    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.

    J-18808-Ljbffr

    If your compensation planning software is too rigid to deploy winning incentive strategies, it’s time to find an adaptable solution. Compensation Planning
    Enhance your organization's compensation strategy with salary data sets that HR and team managers can use to pay your staff right. Surveys & Data Sets

    What is the career path for a Associate Director, GCP Compliance?

    Sign up to receive alerts about other jobs on the Associate Director, GCP Compliance career path by checking the boxes next to the positions that interest you.
    Income Estimation: 
    $55,598 - $84,145
    Income Estimation: 
    $35,250 - $44,591
    Income Estimation: 
    $42,577 - $59,931
    Income Estimation: 
    $150,417 - $183,047
    Income Estimation: 
    $195,602 - $261,706
    Income Estimation: 
    $58,078 - $76,693
    Income Estimation: 
    $73,707 - $95,263
    Income Estimation: 
    $80,876 - $132,043
    Income Estimation: 
    $77,899 - $100,402
    Income Estimation: 
    $195,602 - $261,706
    Income Estimation: 
    $244,337 - $383,019
    Income Estimation: 
    $123,739 - $165,355
    Income Estimation: 
    $163,270 - $214,905
    Income Estimation: 
    $150,417 - $183,047
    View Core, Job Family, and Industry Job Skills and Competency Data for more than 15,000 Job Titles Skills Library

    Job openings at Takeda Pharmaceuticals

    Takeda Pharmaceuticals
    Hired Organization Address Lexington, MA Full Time
    Job Description Position Overview: We are seeking a highly motivated and detail-oriented Diagnostic Devices Engineer to ...
    Takeda Pharmaceuticals
    Hired Organization Address Lexington, MA Full Time
    Job Overview We are seeking a highly motivated and detail-oriented individual to lead technical project management withi...
    Takeda Pharmaceuticals
    Hired Organization Address Lexington, MA Full Time
    Job Description As a Digital Drug Product Development Associate Scientist, your primary responsibility will be to develo...
    Takeda Pharmaceuticals
    Hired Organization Address Lexington, MA Full Time
    Company Overview Takeda is a global leader in R&D, driving innovation and delivering transformative therapies to patient...

    Not the job you're looking for? Here are some other Associate Director, GCP Compliance jobs in the Honolulu, HI area that may be a better fit.

    Compliance Director

    AlohaCare, Honolulu, HI

    Director, Compliance Operations

    WelbeHealth, Honolulu, HI

    AI Assistant is available now!

    Feel free to start your new journey!