Manager QMS Systems

Company: Takeda Pharmaceutical
Location: Rochester
Posted on: January 27, 2023

Job Description:

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Job Description

OBJECTIVES:

• Provide support to the GRA organization on the training identification, assessment and administration for QMS systems.
• Provide leadership and QMS Training Systems operational expertise in the identification, creation, and execution of GRA Compliance QMS initiatives to drive overall compliance and growth, while meeting Takeda corporate objectives.
• Partner effectively with cross functional teams, in the proactive identification of key regulatory compliance QMS training issues with the ability to determine actionable project proposals and drive them to successful resolution.
• Provide GRA QMS expertise in the development and maintenance of key compliance activities (e.g. training, documentation, and deviations/CAPA as appropriate)
• Provide data to in support of the GRA training metrics program and communication to organization with an eye on risk, trends, and remediation recommendations/actions. ACCOUNTABILITIES:
  • Support the GRA QMS training key elements (Deviations, CAPA and Change Control) partnering with the GRA SMEs to ensure the timely and successful completion.
  • Drive GRA QMS training initiatives and implementation strategies with alignment to stakeholders which may include Takeda Global Quality, R&D Quality and Global Regulatory Affairs organizations.
  • Evaluate, develop and effectively communicate to key stakeholders GRA Compliance QMS training project and program results, identification of potential regulatory risks, and risk mitigation/resolution strategies.
  • Manage compliance training cross functionally, GRA functional teams and Takeda 3rd party contractors, as necessary, in the execution of QMS project plans, deliverables and implementation of resolutions to ensure compliant GRA processes.
  • Interact with all levels of GRA Management to present risks, strategies troubleshoot and remediation for compliance training activities.
  • Provide GRA QMS training systems and process guidance aligned with overall governance activities within GRA, and across R&D and Global Quality.
  • Identify and inform GRA QMS training process best practices into the Takeda/GRA business processes to ensure delivery aligned with company initiatives and expectations.
  • Develop and sustain strong partnerships with cross functional leadership and third parties to optimize delivery of GRA QMS programs and projects ensuring alignment to R&D metrics outputs, driving accuracy.
  • Lead and engage in efforts to simplify and optimize GRA QMS training processes, systems, and platforms to drive organizational alignment and growth. EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
    • Bachelor's Degree or equivalent years (5-7+) of relevant experience
    • 5+ years of experience in Pharmaceutical industry, preferring regulatory affairs, research and development, quality assurance/compliance.
    • Strong GxP systems knowledge (LMS, DMS, CAPA/Deviations) such as Success Factors, Veeva Vault, and Trackwise
    • Strong understanding of metrics, risk analysis, tracking and trending of compliance activities.
    • 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, quality pharmaceutical and regulatory affairs requirements and practices.
    • Practical operational experience working across disciplines within a global environment.
    • Experience working strategically within a global team 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 process 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 ideas clearly and concisely to a variety of audiences.
    • Ability to understand/analyze/synthesize and communicate to internal/external stakeholders.
    • Must be able to lead as part of a global team, and deliver results in a matrix organization.
    • Strong project management capabilities. EEO Statement
      
      Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
      
      Locations
      
      Cambridge, MA
      
      Worker Type
      
      Employee
      Worker Sub-Type
      
      Regular
      Time Type
      
      Full time

Keywords: Takeda Pharmaceutical, Rochester , Manager QMS Systems, Executive , Rochester, New York