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Head of Rare Genetic and Hematology, Clinical Quality Assurance (Director, Hybrid Remote)

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Job ID R0048196 Date posted Sep. 20, 2021 Location Remote

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Job Description

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. 

Here, everyone matters, and you will be a vital contributor to our inspiring, bold mission.

SUMMARY:

This key leadership role provides professional expertise and strategic GCP and quality leadership to the Rare Genetic and Hematology Therapeutic Area Unit (TAU) for drug development programs, partnering closely with key R&D leaders and R&D Quality. In addition, it directs and oversees the risk-based GCP audit and oversight strategy for TAU global development programs, communicating critical compliance risks noted from these activities to senior management, and ensuring that corrective and preventive actions are implemented.        

KEY ACCOUNTABILITIES:

  • Provides GCP and quality expertise and strategic leadership to the Rare Genetic and Hematology Therapeutic Area Unit (TAU) for drug development programs, partnering with key R&D leaders and R&D Quality personnel
  • Oversees the risk-based GCP audit and compliance strategy for TAU global development programs, communicating critical compliance risks noted from these activities to senior management, and ensuring that appropriate actions are implemented to mitigate risks
  • Provides strategic leadership, guidance and support to Clinical QA Program Leads (PLs) to enable successful development and implementation of risk-based audit and compliance strategies to support TAU development programs
  • Oversees the hiring, assignments, goals, performance and ongoing development of CQA PLs; ensures CQA audit and compliance deliverables follow Takeda procedures and monitors performance of external CQA auditors
  • Analyzes audit and compliance metrics to identify risks and evaluate the state of GCP compliance; presents analyses to TAU and Quality leadership and provides guidance for key stakeholders to make critical decisions

MINIMUN REQUIREMENTS:

  • BS/BA Degree required; advanced degree preferred
  • Minimum 10 years of industry experience in GCP QA and/or Clinical Operations with advanced experience in GCP auditing preferred
  • Expert knowledge of GCP and understanding of global clinical development required
  • Experience working within pharmaceutical or biotechnology organizations
  • Minimum 7 years of experience in the conduct and reporting of GCP audits and the translation of findings into corrective and preventive actions plans that mitigate risks to the company, to patient safety and data integrity

PREFERRED QUALIFICATIONS:

  • Ability to collaborate with and achieve results through others; builds strong and sustainable relationships and interact within all levels of the organization
  • Possess outstanding leadership and interpersonal skills with a management style which encourages open expressions of ideas, opinions, and a full discussion of differing points of view. Sound judgment and independent initiative.
  • Demonstrated ability to succinctly translate and effectively communicate the potential impact of significant and complex issues.
  • Ability to read, analyze and interpret common scientific and technical journals, financial reports, and legal documents. Ability to effectively present information to senior management, internal stakeholders, and external partners  
  • Ability to manage assignments and effectively deliver all expected deliverables in an organized and a timely manner and proactively communicate changes in pre-established goals and deadlines.

#GMSGQ

This job posting excludes CO applicants

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

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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