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Title: Clinical Quality Assurance Program Manager
Company: Takeda Pharmaceuticals
Location: Boston, MA

Be empowered to take charge of your future at Takeda. Join us as a Clinical Quality Assurance Program Manager in our Cambridge office. As a Program Manager 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:

  • Lead the management of audits, quality issues and investigations, and inspections. This position requires sufficient understanding, experience in GCP and compliance, leadership, communication skills, and business acumen to conduct responsibilities with supervision.
  • Provide 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; and enable teams to be inspection ready, in support of a culture of sustainable compliance… 

Requirements:

  • BS/BA degree required; advanced degree preferred.
  • Minimum of 5 years of experience in the pharmaceutical, biotechnology or related health care industry. 
  • Minimum 2 years of GCP-related Quality Assurance or relevant clinical trial experience.
  • Knowledge and/or awareness of ICH GCP R2 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/CQA-Program-Manager_R0019961-1

SOCRA Exp: 8/28/2020