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Title: Clinical Quality Assurance Associate Director
Company: Takeda Pharmaceuticals
Location: Boston, MA

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. Join us as a Clinical Quality Assurance Project Lead/ Asc Dir in our Cambridge office. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Director working on the R&D Quality Assurance team, you will be empowered to lead Clinical Quality Assurance (CQA) activities for assigned clinical development programs, and a typical day will include:

OBJECTIVES:

  • Responsible for the management of audits, quality issues and investigations, and inspections. This position requires a depth of understanding and significant experience in GCP and compliance, leadership, communication skills, and business acumen to conduct responsibilities independently.
  • Provide professional expertise and guidance on Good Clinical Practice (GCP) and applicable regulations to clinical development teams to proactively identify compliance issues/risks and recommend mitigations
  • Liaise with various Takeda R&D functions and external parties including contract auditors and investigator sites to promote a high level of quality and consistency across and within programs; develop the risk-based audit and compliance strategy for assigned programs; assist project teams in implementing corrective and preventive actions; 

Requirements:

  • BA/BS degree required; advanced degree preferred.
  • Minimum of 10 years of experience in the pharmaceutical, biotechnology or related health care industry.
  • Minimum 7 years of GCP-related Quality Assurance or relevant clinical trial experience.
  • Extensive knowledge and/or awareness of ICH GCP and applicable global regulations and guidance for clinical development

To apply for this position, please visit: https://takeda.wd3.myworkdayjobs.com/External/job/Boston-MA/Associate-Director--Clinical-Quality-Assurance-Program-Lead_R0016399-1

SOCRA Exp: 8/28/2020