Posted to MedZilla on 11/14/2019

Takeda Pharmaceuticals

US-MA, GRA Compliance Manager R0012150-MZ


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Job Description

OBJECTIVES: (Briefly summarize the overall purpose of the position. Objectives should

be written in 3 4 bulleted statements).

  • Responsible for the ongoing maintenance and support of the GRA Global Quality and Compliance Systems, ensuring overall compliance and effectiveness of the GRA quality system.
  • Program Management of key GRA Quality and Compliance initiatives that drive continuous improvement of the GRA and Takeda systems. Coordinate and participate in audits and inspections in GRA globally.
  • Facilitate the GRA compliance to the GRa Quality systems to ensure compliance to standards and new/revised Global GxP Requirements. Ensures that personnel are aware and responsive to external guidelines and regulations as they pertain to GxP Regulatory processes.
  • Lead and/or support the monitoring, measurement and effectiveness of all GRA QMS processes including but not limited to; training, procedure management, change control, quality event and deviation management, audit and inspection management and QMS continuous improvement projects.

ACCOUNTABILITIES: (Describe the primary duties and responsibilities of the job. Include only the essential functions of the job. Approximately 5 10 bulleted task statements should be identified).

  • Ensure compliance for the Regulatory Organization, including internal and external teams and partners, and support project leaders through the program management of key GRA Compliance and Quality Systems initiatives.
  • Participate and execute the development and implementation of Compliance monitoring processes across Global Regulatory Affairs.
  • Facilitate the implementation of inspection/audit readiness activities to include training, facilitation, internal assessments across GRA functions.
  • Support and collaborate across R&D functions in the management of audit/inspection GRA related observation responses
  • Partner with R&D QA and interfaces with other Takeda disciplines in the identification and management of global initiatives and participate in global projects for QMS and compliance development and maintenance.
  • Develop and analyze compliance metrics, and identifies potential improvement activities. Communicate issues/trends to Compliance management.
  • Maintains an expert, current knowledge of regulations, legislation, best practices and guidelines relating to Regulatory Affairs as well as GVP and GCP.
  • Support GRA in Inspections and audits covering readiness activities, fulfilment of requests and the management of any outcomes.
  • Develop and maintain the GRA Business Continuity Strategy and plan in collaboration with the Leadership and QMS team.
  • Support overall regulatory intelligence efforts to ensure GRA maintains overall compliance to new and revisions to Global regulatory requirements as they impact GRA.







line management, on the org chart


org chart; employees below direct reports.






EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: (List the essential and desirable education and competency requirements to perform the primary responsibilities of the job. Any minimum requirements should be noted.)

Education and Experience Required:

  • Bachelor s Degree in a science or business-related field.
  • 3+ years of experience in Pharmaceutical industry, with 3 years in Regulatory Affairs, research and development, quality assurance/compliance.
  • Familiarity with inspections and audit procedures.
  • Ability to identify proactively and anticipate risk of non-compliance in a complex environment.
  • Demonstrated knowledge of global health authorities, regulations, product approval and lifecycle processes for major markets and of pharmaceutical and regulatory affairs requirements and practices.
  • Practical operational experience of working across disciplines and across multiple regions. Experience working within a global team framework and a multi-cultural environment. Efficiently/actively manages conflict in a tactful, diplomatic way, seeking effective solutions for all parties.
  • Able to manage both time and priority constraints and to manage multiple priorities simultaneously.
  • Capability to critically analyze complex and/or ambiguous information and the impact on products and process and to effectively communicate complex issues both verbally and in writing.
  • Excellent analytical, technical and problem-solving skills
  • Strong communication skills with the ability to express oneself clearly and concisely to a variety of audiences. Ability to understand/analyze/synthesize and communicate to internal/external stakeholders.
  • Must be able to lead cross-functional and cross regional teams and deliver results in a matrix organization. Excellent organizational skills and ability to prioritize as well as Project Management abilities


  • None required.

PHYSICAL DEMANDS: (Identify any physical demands required in the performance of the primary responsibilities of the position).

  • Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
  • Carrying, handling and reaching for objects.
  • Ability to sit or stand for long periods of time while traveling


  • International travel may be required in accordance with compliance/program requirements
  • Ability to attend offsite meetings that may involve overnight stay


ADDITIONAL EUROPE SPECIFIC INFORMATION (FOR EUROPEAN RECRUITMENT ONLY): This section should reiterate minimum/essential requirements for role


Boston, MA

Worker Type


Worker Sub-Type


Time Type

Full time

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