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Director, GCP Compliance - REMOTE

Employer
Takeda
Location
Massachusetts - Virtual, Massachusetts
Start date
May 23, 2023

View more

Discipline
Regulatory, Legal/Compliance
Required Education
Bachelors Degree
Position Type
Full time

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’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

OBJECTIVES/PURPOSE

  • Lead/drive development and implementation of compliance management for clinical trial delivery including quality event determination and documentation, liaising with QA and managing & closing CAPAs; Report non-compliance as needed
  • Establish and lead proactive compliance framework for clinical trial delivery functions, overseeing direct reports and functional service provider resources; establish key performance indicators for clinical trial delivery, leadership reporting and mitigation strategies.
  • Develop, lead and drive clinical trial delivery metrics and reporting including but not limited to training and CAPA completion compliance

ACCOUNTABILITIES

Proactive GCP Oversight

  • Establish, build and lead proactive compliance framework for clinical trial delivery functions, overseeing direct reports and functional service provider resources
  • Partner with R&D QA on GCP compliance strategy; collaborate and enable multilevel corrective and preventative actions with QA, Process Training and Digital Solutions, and cross functional clinical trial delivery functions
  • Establish, build and manage proactive compliance project management team to plan, implement, manage and report processes to determine adherence and understanding of ICH GCP requirements and Takeda processes
  • Provide near real-time feedback on study process and documentation quality as well as team performance and understanding on evaluated processes.
  • Identify, strategize and facilitate solutions to identified areas of concern with cross functional clinical trial delivery stakeholders

GCP Compliance Metrics and Reporting

  • Establish key performance indicators for clinical trial delivery, leadership reporting and mitigation strategies to track process quality and compliance
  • Partner with clinical trial delivery functions, R&D QA and other stakeholders on performance metrics, analytics and reporting for GCP compliance activities
  • Oversee direct reports and/or functional service providers on GCP metrics and analytics team
  • Develop strategy and implementation plan for development and maintenance of KPIs, metrics and dashboards to track process quality and compliance

GCP Quality Liaison

  • Establish compliance GCP Quality Liaison network responsible for clinical trial delivery deviation and CAPA management including deviation determination, documentation, liaising with QA and managing & closing CAPAs; Report non-compliance as needed
  • Srategize and lead study teams and functional areas in CAPA definition for deviations, audits and inspections.
  • Manage CAPA reporting for clinical trial delivery and facilitate leadership review; work with functional areas to solve compliance gaps
  • Lead compliance and oversight for GCP Quality Plan; strategize and collaborate with R&D QA on next steps and actions

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • Bachelor’s Degree or international equivalent required, Life Sciences preferred
  • 10+ years experience in the pharmaceutical industry and/or clinical research organization, including 6+ years in clinical study management, including at least 6 years of line management experience
  • Experience in people leadership, managing global teams and coordinating collaboration with cross-functional teams
  • Strong strategic thinking, planning, execution, and communication skills
  • Global/international experience required, including ability to collaborate with colleagues and staff in other locations
  • 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

Base Salary Range: $160-229K. Employees may also be eligible for Short Term and Long-Term Incentive benefits. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.

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

#LI-Remote

Company

Takeda is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its 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. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions.

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

Stock Symbol: TAK

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

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