Posted to MedZilla on 9/20/2019

Takeda Pharmaceuticals

US-MA, Manager, Good Pharmacovigilance Practices Quality Operations R0010632-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 Manager, GVP Quality Operations in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Manager working on the R&D Quality team, you will be empowered to support global functions of GPSE, GMA and GRA (excluding CMC) in the implementation of Takeda Quality Management System (QMS) methodology, infrastructure and tools, and a typical day will include:


  • Works with identified stakeholders to implement quality standards, systems, and metrics for maintaining compliance
  • Act as contact for process development/ optimization
  • Lead investigations impacting the PV System for global stakeholders


  • Partner with assigned stakeholder group(s) to execute strategy to achieve and maintain the desired high state of quality including, on an ongoing basis understand, communicate, and mitigate compliance risk
  • Lead quality investigations that have an impact on the PV System, working with stakeholders to develop actionable plans
  • Assist in the development and maintenance of quality standards that are compliant with global regulatory requirements, aligned with Takeda and Global Quality requirements, and current industry trends and best practices.
  • Participate in Operational Excellence initiatives such as Six Sigma and Kaizen events.
  • Support emerging regulations and develop proactive compliance programs
  • Assess data available and provide to stakeholders, as requested


Education & Experience

  • Bachelor s Degree required; Advanced Degree preferred.
  • Minimum 5 years of increasing responsibility in pharmaceutical, GCP- and/or GVP related Quality environment.
  • Minimum 3 years of people and/or process management experience in GCP and/or GVP Quality Assurance
  • Experience in managing complex organizational compliance issues and in identifying and implementing organization-wide compliance initiatives
  • Skilled in managing global, cross-functional projects


  • Regulatory Knowledge - Knowledge of global GVP regulations and guidances; good working knowledge of global GCP, GMP and GLP regulations and guidances. Understands the regulatory environment for global pharmaceutical companies, as well as best practices in the Pharma industry to satisfy regulatory requirements.
  • Industry Knowledge Working knowledge of the pharmaceutical industry and the new drug development process; understands the phases, processes and techniques used in the science of pharmacovigilance.
  • Knowledge in the conduct and reporting of audits and investigations, as well as the translation of findings into corrective action plans that mitigate risks to the company, to safety and data integrity.
  • In-depth understanding of the good practices for the creation and management of a Quality Management System.
  • Scientific Knowledge - Possesses the necessary science education and knowledge to provide Quality Assurance oversight.
  • Communication Skills - Must professionally, clearly, concisely and consistently communicate to external and internal customers, both verbally and in writing. Must demonstrate professional presentation skills.
  • Negotiation Skills - Demonstrates proficiency in negotiation and conflict resolution.
  • Project Management - Demonstrates proficiency in managing complex projects, delivering all expected deliverables in a timely manner, and proactively communicating changes in pre-established goals and deadlines.
  • Organizational Skills - Must be able to prioritize work effectively to meet timelines, and delegate to subordinates.
  • Interpersonal - Must be able to adapt to other personalities in a respectful manner that is conducive to goal achievement and team building.
  • Computer skills - Must be able to efficiently utilize the computer hardware and software programs provided to plan, manage, conduct and track deliverables and to communicate with internal and external team members.


  • ASQ Certified Quality Auditor (CQA), ASQ Certified Manager of Quality/Organizational Excellence, or SQA Registered Quality Assurance Professional or equivalent preferred.
  • Six Sigma Green Belt preferred.


  • Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
  • Carrying, handling and reaching for objects.


  • Position is located in Boston.
  • Ability to drive to or fly to various meetings or client sites, including overnight trips. Some international travel will be required.
  • Requires approximately 10 % 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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