Posted to MedZilla on 9/22/2019

Takeda Pharmaceuticals

US-MA, Clinical Quality Assurance OPEX Program Manager R0010697-MZ


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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. Join us as a Clinical Quality Assurance OPEX Program Manager in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Program Manager working on the R&D Quality Assurance team, you will be empowered to support the entire Clinical Quality Assurance team in audit, inspection and compliance related activities, and a typical day will include:


  • Coordinate and support execution of the risk-based GCP supplier audit and compliance strategy
  • Manage GCP consultant auditors and auditor partners
  • Provide professional expertise in applicable guidance and regulations, proactively identifying potential areas of non-compliance and risk to Takeda


  • Manage GCP consultant auditors, including identification, qualification, selection, training and management of the ongoing performance of auditors
  • Assist CQA team with provision of material to contract auditors prior to audits
  • Develop and maintain relationships with external auditor partners
  • Coordinate the development and execution of Scope of Work, Master Service and Quality Agreements for CQA auditors and suppliers
  • Develop and maintain the global GCP Supplier audit management plan in accordance with Takeda procedures
  • Support GCP supplier quality governance council meetings, as needed
  • Support CQA team with entry of information into audit database
  • Lead periodic review of the CQA audit system
  • Generate metrics reports from audit and compliance databases for CQA team analysis and reporting
  • Maintain the global CQA Sharepoint site
  • Assist and provide training to CQA team members on audit and compliance databases and CQA Sharepoint site
  • Escalate systemic and/or critical problems to CQA management
  • Participate in GCP health authority inspections as required
  • Develop and/or review procedures and participate in process improvement initiatives, as needed.
  • Provide miscellaneous administrative support as required.


  • BA/BS degree required.
  • Minimum of 5 years of experience in the pharmaceutical, biotechnology or related health care industry
  • Knowledge and experience in GCP, quality, and compliance to conduct responsibilities with input and direction, as needed, from supervisor and other CQA team members
  • Understanding of GCP audit conduct and reporting
  • Collaborative team player with a positive attitude that desires to learn and develop in CQA
  • Ability to communicate professionally, clearly, concisely and consistently to external and internal customers, both verbally and in writing.
  • Strong judgment, project management and decision-making skills; able to prioritize and manage multiple projects and demanding timelines
  • Attention to detail and ability to analyse complex data


  • GCP Quality Assurance registration/certification preferred


  • Routine demands of an office-based environment


  • Willingness to travel to various meetings and/or audits, including overnight trips. Some international travel may be required.
  • May require up to 20% travel


  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement
  • Company match of charitable contributions
  • Health & Wellness programs including onsite flu shots and health screenings
  • Generous time off for vacation and the option to purchase additional vacation days
  • Community Outreach Programs

Empowering Our People to Shine

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Cambridge, MA

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Full time

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