Massachusetts Green Jobs

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Job Description

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 become the model for the industry.

Complexity

• 30+ external Contract Manufacturing Organizations (CMOs)

• Products dispositioned represent 10,500+ Oku Yen of sales

Important Considerations

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:

• May be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.

• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.

• Work in a cold, wet environment.

• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.

• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

#GMSGQ #ZR1 #LI-MA1

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Boston, MA

U.S. Base Salary Range:

$300,800.00 - $413,600.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time