Head of Vaccines Ms&t Validation

Our team is growing and for this we need bright minds with creativity and flexibility - **what talent do you have?**

**OBJECTIVES**:

- Partner with organizations across Takeda and sponsor the establishment operational excellence as a way of working within VO which includes a focus on Quality by Design for our programs to enable: 1) delivery of phase appropriate development/validation deliverables; 2) seamless transitions such that programs are PPQ ready when required; 3) successful commercialization of validated processes/products; 4) a mindset and infrastructure that promotes continuous improvement capabilities.
- Champion, lead and support projects in clinical and commercial production which involve the development and implementation of comprehensive validation strategies (e.g. validation master planning) as well as the authoring of validation deliverables in support of projects, inclusive of the preparation of regulatory filings.
- Sponsor, establish, support and direct collaborative projects with other VBU functions (e.g. CMC, Technical Operations, Manufacturing, Quality) and External Partners (CMOs) to generate and execute process / product technology transfers and the associated qualification/validation activities in support of clinical/commercial milestones.

**ACCOUNTABILITIES**:

- Ability to lead as well as provide oversight for the delivery of the required phase-appropriate end-to-end product/process validation lifecycle deliverables (e.g. product/process development plans, technology transfer plans, validation master plans, process control strategies, technical/quality risk assessments, validation protocols/reports, etc.) for products produced by Takeda and its CMO partners in support of clinical and commercial objectives.
- Serve as a change agent to partner with internal and external stakeholders to develop strategic roadmaps and corresponding execution plans which install Quality by Design (QbD) / OpEx solutions that address the most critical business needs.
- Provide ongoing technical support to bolster the technical/compliance posture of the phase-based validation program associated with the manufacture Takeda’s clinical and commercial products.
- Support includes and is not limited to support of process change control, deviation investigations, CAPA management and regulatory filings/inspections.
- Champion functional projects/initiatives and lead/facilitate teams to install QbD and Operational excellence (e.g. LSS, Agile, etc.) practices which enable a transformation in the organizations’ capability to deliver innovative products/solutions.
- Effectively sponsor, influence and manage cross-functional project teams to promote a culture of team accomplishment, continuous improvement, an entrepreneurial spirit and encourage career growth/development.

**EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS**:

- 15+ years relevant experience, including strategy development and process validation in biotechnology / pharmaceutical industry
- Proven ability to design, implement and sustain validation programs. Demonstrated experience / technical knowledge with process validation is required.
- Experience in development and implementation of process control strategy using QbD principles
- Seasoned direct interaction /experience with Global Boards of Health during inspections and submissions in support of clinical/commercial production is a plus.
- Working knowledge of statistical process control concepts, data analysis, diagnostic tools and techniques.
- Experience with OpEx models such as Six Sigma, Malcom Baldrige, Shingo, etc.
- Experience deploying Lean Tools such as Value Stream Mapping, Heijunka, Kanban, Takt Time, Poka-yoke, etc.
- Expertise in Change Management.
- Cultural agility and experience working in fast-paced and cross-functional environments
- Learning Management Systems/GMP experience.
- Experience leading and managing others
- Ability to influence, enable, and lead change within large organizational units
- Business acumen, problem solving, and solid understanding of biopharmaceuticals value chain
- Experience using design thinking to problem solve (from identifying business challenges to deployment / execution of solution)
- Strong project management, analytical and quantitative modelling skills
- Excellent interpersonal skills and team orientation
- Excellent verbal and written communication skills

**TRAVEL REQUIREMENTS**:

- Position requires up to 30-35% travel (both domestic and international travel required).

**Empowering our people to shine**

At Takeda, we earn the trust of society and our customers through our values of Takeda-ism: Integrity, Fairness, Honesty, Perseverance. We incorporate these values in everything we do. They represent who we are and how we act. They help us make decisions that we can be proud of today and in the future. We enable our employees to develop their full potential. As a global top employer, we offer exciting career paths, promote innovat