Head of Quality, Biologics Operating Unit
2 weeks ago
**Job Title**: Head of Quality, Biologics Operating Unit
**Location**: Cambridge, MA
**About the role**:
- The Head of Quality, Biologics OpU has overall accountability for Quality for internal and external manufacturing sites and contract laboratories, Product Quality Leaders and above site functions in the Biologics network. This includes Quality Assurance, Quality Control, Quality Systems, Quality Compliance and Quality Services and Improvements, including execution of Quality Stategy improvement projects, talent management and financial oversight.
- A key member of the Global Quality Leadership Team, and the Biologics Operating Unit Leadership Team, the Head of Quality, Biologics OpU will be required to set the longer-term strategy and plans for the function, establish priorities, build a global patient-centered best in class organization, develop diverse talent and elevate organizational performance, and manage the overall finances of this function.
**How you will contribute**:
- Execute the Quality Management System for internally and externally manufactured Biologics
- Quality Assurance and Quality Control for Drug Substance, Drug Product, Drug Product and Finished Goods. This includes batch review and releases, analytical reviews including stability programs and risk based deviation reviews for Biologics.
- Establish Quality Compliance and Systems including Change Control Management and Supplier Quality Management, Inspection Management, Metrics and KPIs, Complaints, Product Quality Communications
- Quality Service & Improvement including budgets and resource planning, collaboration with SMO and CTLs on lab transformations and operational excellence
- Quarterly quality reviews of strategic CMO’s / CTLs and collaboration with GMS to improve efficiency/KPI’s of CMOs, CTLs
**What you bring to Takeda**:
Education / experience
- Scientific degree (BSc, MSc, PhD)
- 15+ years of increasing management responsibility combined with strong technical operations background
- Leadership experience in site and above site quality functions and working in a global environment
- Effective finance and controlling knowledge and competencies
- Fluent in written and spoken English
Core Competencies / Skills
- Critical Thinking
- Current on local and global regulations
- Understanding of biologics manufacturing
- Digital and analytical skills
- Investigation and problem solving
- Strong communication skills engaging stakeholders: site, business, network, company, regulators
- Risk identification, evaluation and management
- Continuous improvement
Leadership Behaviors
- Strategic enterprise thinking, finding innovative ways to serve patients build reputation and trust
- Creating the environment that inspires and enables people
- Focusing on the few priorities and provide superior results
- Elevating capabilities for now and the future
**Technical/Functional (Line) Expertise**
- Knowledge and experience of Bio-Pharmaceutical Manufacturing
- Knowledge of Continuous Improvement and digital programs
- Knowledge and understanding of relevant regulations enabling effective partnership with GMS
- Knowledge of Takeda strategy and business performance
**Leadership**
- Ability to lead a global function, leveraging an extensive and complex network of external or internal Contract Manufacturing Organizations (CMO)
- Ability to build a customer & patient-centered best in class organization, develop diverse talent and elevate organizational performance, by partnering with stakeholders such as GMS, Quality Systems and Compliance, Quality Strategy & Business Operations, Procurement and Manufacturing Sciences, Quality Compliance and Systems
- Ability to operate cross functionally, working with GMS, Procurement, Product Managers / Product Quality Leaders, Manufacturing Sciences
- Ability to make significant Quality decisions enabling Takeda to deliver on its commitment in line with Takeda values
**Decision-making and Autonomy**
- DOA limits to be defined in line with TMAP
- A member of the GQLT - setting the long term strategy for Global Quality
- A member of the Biologics Operating Unit Leadership Team
- Responsible for Global Quality Councils and resulting management actions
- Responsible for participating in Quality Alignment Meetings and Market Action Committees for market products
- Full budget accountability for this function
**Interaction**
- Key Stakeholders include: Global Supply Chain, Procurement; Internal Manufacturing sites, Manufacturing Sciences, Quality Compliance and Systems and Compliance and Quality Strategy & Business Operations & Finance
**Innovation**
- Unique contribution of thought, experience, background, and skills in leading the development and implementation of an Biologics Quality Strategy to deliver against the Global Quality Roadmap
- A firm grasp of industry, scientific and regulatory trends, understands market conditions, and develops strategies to evolve Takeda’s regulatory profile to bec
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