Posted to MedZilla on 5/29/2017

Takeda Pharmaceuticals

US-MA, Manager Quality Systems and Compliance 1700839-MZ


  • Implement GLP Quality Systems and Compliance processes which support the non-clinical research activities and the Research Quality organization. This role partners with US colleagues to ensure GLP compliance.
  • Implement strategic direction for Quality Systems and Compliance elements to ensure a state of compliance and agreement with regulatory requirements, as well as Global Quality Standards and expectations.
  • Responsible for conducting quality system and compliance audits supporting the conduct and outsourcing of GLP studies in the US.


  • Lead and conduct audits; Issue audit reports and perform follow-up actions
  • Review / audit compliance documents, SOPs, and protocols as assigned; report findings to management as necessary
  • As required, participate in inspections and audits by regulatory agencies; investigate and resolve observations noted during audits / inspections; participate in inspection readiness activities
  • Maintain a current GLP training program to ensure that personnel are appropriately trained to carry out assigned responsibilities
  • Conduct audits to monitor the state of compliance of service providers.
  • Interact with and influence colleagues in Research division and Research Quality in order to strategically align and facilitate harmonization of quality systems, procedures, and processes where necessary.
  • Reading, interpreting and applying various regulations and guidance documents. Assessing compliance with said documents.
  • Additional duties as assigned


  • Bachelor degree required
  • Minimum 5 years of experience in Quality Assurance; Pharmaceutical industry experience preferred
  • Minimum 3 years GLP QA experience
  • Good knowledge of international regulatory requirements and industry guidelines for global GLP
  • Accreditations or certifications preferred (e.g. RQAP-GLP)
  • Ability to read, interpret and apply references
  • Ability to identify issues and offer solutions in a pragmatic way
  • Demonstrated ability and willingness to learn new knowledge and skills
  • General knowledge of drug development process
  • Good written and verbal communication skills in English
  • Excellent business skills such as critical thinking, strategic planning, and self-management
  • Must be able to handle multiple demands calmly and with patience
  • Confidence to work alone or in a team
  • Good attention to detail, with the ability to see the big picture
  • RQAP-GLP preferred
  • Office work
  • Travel required, approximately 25-35%, both domestic and international.

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