Quality External Engagement (Sr Director)

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Job Description

About the role:

About the role:
The Senior Director Quality Compliance and Systems is responsible for ensuring the quality of processes and product outputs. This role involves defining activities, processes, and standards to meet quality requirements, auditing and monitoring processes, and ensuring compliance with corporate and regulatory standards. By maintaining high-quality standards, this role supports Takeda's commitment to delivering exceptional products and services.

How you will contribute:
* Define and specify activities, processes, and standards to fulfill quality requirements
* Audit, monitor, and determine the quality of processes or outputs against defined standards
* Conduct product integrity testing and ensure compliance with quality requirements
* Report on process deviations and defects
* Oversee multiple teams led by Senior Managers and Managers
* Shape corporate policies and provide guidance to directors and senior managers
* Interact with executive leadership on significant organizational matters

Skills and qualifications:
* Can independently execute validation protocols in routine and moderately complex situations, demonstrating a comprehensive understanding of testing strategies and quality benchmarks.
* Applies Good Manufacturing Practices independently in routine and moderately complex situations with minimal guidance.
* Able to independently execute qualification protocols for installation, operational, and performance qualification in routine scenarios.
* Performs cleaning validation independently, ensuring machinery is contaminant-free.
* Manages change control procedures for routine and moderately complex changes effectively.
* Implements Corrective And Preventive Action strategies independently, identifying flaws and formulating preventive measures.
* Conducts risk analysis independently, applying standard and some advanced strategies for mitigation.
* Manages projects independently, employing a comprehensive understanding of project management principles.
* Conducts audits independently in routine and moderately complex situations, with a comprehensive understanding of auditing principles.
* Drafts and adheres to a Validation Master Plan for routine and moderately complex processes.
* Applies regulatory compliance independently in routine and moderately complex situations.
* Applies Continuous Improvement Process principles independently, showing a comprehensive understanding of the concepts and methodologies.

As a strategic leader overseeing multiple functional areas, divisions, or product groups through directors and managers, with global or multi-country-level responsibility. You will shape corporate policies, provide guidance to directors and senior managers, and hold a recognized influential position. Your decisions impact the success of the division, group, company, or corporation, and you may sit on a leadership team, directly influencing the overall business strategy of your area.

• To define and implement an external engagement strategy, governance and associated capabilities to ensure that Takeda is recognized by GxP regulatory authorities and industry peers as a thought leader in the areas of innovation, science/technology, quality and compliance. 
• Engages with key quality pharmaceutical and life sciences industry associations to represent the company on quality and compliance strategic topics.
• Design and implement governance processes and cross-divisional/cross-functional governance bodies that support the nomination and participation of internal leaders and subject