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.

SCOPE OF SUPERVISION:

NUMBER SUPERVISED WORKERS

Direct

In-Direct

Employees

0-2

line management, on the org chart

0-2

org chart; employees below direct reports.

Non-Employees

0-2

consultants

0-2

PRA, IQVIA

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

LICENSES/CERTIFICATIONS:

  • 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

TRAVEL REQUIREMENTS:

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

ADDITIONAL US SPECIFIC INFORMATION (FOR US RECRUITMENT ONLY): E.g. Number of years experience, ADA

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

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time


Please visit our website at takedajobs.com

 
 


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