Manager, Vbu Quality Systems

**People First** - At Takeda we are dedicated to improving the health and well-being of all people and bringing them the hope of a brighter future. It is our passion that transforms every job into meaningful action. **Our people are the heart of Takeda.**

The **Quality Systems Manager** supports the overall coordination of the quality systems, including documentation, training, and processes supporting the Takeda Vaccines Business Unit (VBU). The position requires collaboration with numerous functions within the business unit, global Takeda, as well as third party vendors and business partners.
- Works with functional management and other quality colleagues to ensure that all GxP systems are in a state of compliance and inspection readiness.
- The position collaborates with leadership to support and coordinate the development, design, and implementation of global and cross-functional GxP systems, and associated processes and procedures. Provides input to the implementation and support strategies for quality processes and supporting technology, and ensures the integrity, consistency, and harmonization of these processes and systems across the business unit in alignment with global Takeda.

**_ HOW YOU WILL CONTRIBUTE_**

**General**
- Support department reviews, including quality councils and development and implementation of Global Standards and Processes
- Leads Implementation of Continuous Improvement Projects within the Department
- Contribute to create and communicate an employment culture and values which attract, retain, and develop the most effective people.
- Other Responsibilities and Projects as assigned.

**Quality Management System (QMS)**
- Works independently in managing the daily operations of VBU quality systems.
- Supports the development of training initiatives related to Vaccine QMS
- Leads administration of GxP training in support of regulated activities
- Supports implementation of GxP systems across VBU
- Executes developed strategies to ensure best practices are incorporated into the development of documented procedures and specified required training (globally, cross-functionally and regionally)
- Provides advice and expertise to employees to ensure the development, management, and implementation of controlled documented procedures and business critical policy and procedures with associated training are performed based on departmental guidance.
- Acts as primary contact and lead for training and documentation related questions and issues
- Responsible for tracking the overall compliance of training activities
- Leads alignment to ensure the development, management, and implementation of controlled documented procedures and business critical policy and procedures with associated training
- Responsible for quality oversight of VBU GxP document lifecycle states in the DMS
- Responsible for management of VBU GxP training assessments and assignments to applicable personnel
- Facilitates quality metric reporting and periodic assessment of the health of VBU quality systems
- Supports process and technology initiatives for VBU and Takeda quality systems; participate in continuous improvement projects
- Administer training for quality systems, which may include VBU specific user training or training globally within Takeda
- Facilitates the life cycle maintenance of procedures supporting quality systems in compliance with regulations and Takeda policies
- Generate reports, monitor training compliance and perform tracking and trending of relevant training data. Identify and evaluate gaps and develop corrective actions to close gaps.
- Ensure new personnel have appropriate GxP training assignments and provide new hire training for applicable quality systems

**Compliance**
- With the support of Sr. Management, leads the implementation of inspection readiness activities
- Supports implementation of inspection readiness and remediation as needed

**_ DIMENSIONS AND ASPECTS _**

**Technical/Functional (Line) Expertise**
- Experienced leading quality systems management
- Experienced in working with global teams
- Experienced in providing audit support (either remote or on-site)
- Fluent in English (written and oral)

**Leadership**
- Be Positive, Be Accountable, Be Results Oriented
- Excellent communication, interpersonal and organizational skills
- Seeks and uses Quality Conversation as an opportunity for improvement.

**Decision-making and Autonomy**
- Ability to set priorities and to support the Global and Local teams
- Highly flexible and adaptable.
- Ability to make independent decisions based on technical expertise.
- Ability to drive for continuous improvement and results-driven analysis

**Interaction**
- Frequent contacts with equivalent level managers and customer representatives concerning projects, operational decisions, scheduling requirements, or contractual clarifications. Conducts briefings and technical meetings for internal and external representatives.
- Ability to work both in c