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Quality External Engagement (Sr Director)
Takeda
2024-11-14 16:46:39
Lexington,
Massachusetts,
United States
Job type: fulltime
Job industry: Executive Positions
Job description
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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 matter experts in Industry Associations and joint Regulatory/Industry initiatives.
- Ensure early identification and assessment of emerging topics/expectations in the quality GxP compliance/regulatory space to define the company's strategy and involvement, in close collaboration with Quality Systems regulatory intelligence group.
- Collaborates with Global Quality Communications, to ensure timely approval from GQ Communications on all external facing presentations and any accompanying resources, according to corporate guidelines.
- Uses strong interpersonal, persuasive, problem solving and communication skills to facilitate the definition of the program scope, goals and results for all external engagement programs and activities, working closely with GQ Communications.
- Assess the landscape of major GxP and Life sciences industry associations and joint regulator/industry initiatives to decide where the company must be represented and why, including impact expected.
- Contributes to Takeda's external reputation within the Quality and Compliance space, in alignment with GQ Communications. Builds connections and externally liaise to promote Takeda as an industry leader in quality compliance best practices and innovation.
- Manages key relationships and strategies with key quality pharmaceutical and life sciences external groups, trade associations. Responsible for building trust and leading strategic relationships with key industry stakeholders.
- Ensure that an internal Takeda network of subject matter experts exists and supports the internal key opinion leaders in their external engagement activities.
- Designs and implements internal processes and communication mechanisms to assess emerging quality and compliance regulatory expectations for their impact on the company. Proactively escalates how emerging regulatory trends and expectations could impact Takeda's enterprise QMS.
- Establishes global governance, provides oversight and support to all Quality related external engagement activities including among others:
- External Speaking events, i.e. Professional Conferences (keynote speaker, presenters, interest groups, panellists), industry organizations committees, forums;
- Participation on industry technical reports, guidance review and feedback;
- Review and approve all materials referencing Quality Management Systems within Takeda to ensure alignment with all internal global standards and procedures. Coordinate additional review and approval of relevant internal SME's of these materials. Ensure materials have complied with global communications and legal processes prior to any external use.
- Leads and/or supports as required any internal global quality engagement activities such as Quality Summit, Quality Week, Quality Culture or any other global quality engagement activity geared towards quality improvement and innovation.
- Ensures proper mechanism is in place to share in a timely fashion any lessons learned from external engagement activities across the Quality enterprise.
- Develops and manages external engagement SharePoint site as central repository and point of reference for all Quality external engagement initiatives, calendar of activities, links, reference materials, etc.
Technical/Functional (Line) Expertise
- Extensive knowledge and experience of Bio-pharmaceutical Research, Development and Manufacturing
- Knowledge and understanding of relevant emerging regulations and related processes
- Knowledge of diverse therapeutic areas and recent innovative treatments
- Knowledge of SharePoint capabilities.
- Achieve the vision to be recognized by Regulatory Authorities as a thought leader in the Industry in the areas of innovation, science and technology, quality and regulatory compliance, and continuous improvement.
- Strategic role to prepare the internal organization for emerging regulatory expectations in GxP areas, across the lifecycle of biopharmaceutical products at Takeda.
- High visibility of the incumbent representing the company in major industry initiatives and in interactions with regulators, as well as internal visibility with executive leadership.
- A member of Global Quality Compliance and Systems team
- Ad-hoc participation with GQLT as needed
- Responsible for internal processes and systems to support external representation are implemented and effectively working.
- Full budget accountability for designated area
- Benchmarking results and emerging expectations from external activities are communicated effectively across internal divisions/functions and used to drive action and continuously improve internal products, submissions and quality and scientific processes and systems.
- Through the incumbent's contributions with regulators and industry peers, the reputation of the company is continuously enhanced. The company is involved in strategic initiative with regulators and considered a "go to" organization for benchmarking by peer companies and regulators.
- External engagement succession planning process is in place to ensure continuous representation in major Industry Associations/Regulatory forums on the strategy and policy setting level as well as for technical topics.
- A solid grasp of industry, scientific, and regulatory trends to leverage innovations to make Takeda a model for the industry
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