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Quality Disposition,Manager

Lexington, Massachusetts

Overview

Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.

Global Manufacturing and Supply Chain, and Global Quality is the backbone of Takeda, and our employees are the guardians for our patients, our products, and our reputation. As a member of our team, we can offer you the opportunity to grow in a meaningful career, develop your skills, and come to work every day knowing that what you do makes a genuine difference.

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Success

What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.

  • Agile
  • Ambitious
  • Analytical
  • Collaborative
  • Enthusiastic
  • Entrepreneurial

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Opportunity

  • Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

  • Here, you will feel welcomed, respected, and valued as a vital contributor our global team.

  • Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

  • A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2020.

  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

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Quality Disposition,Manager

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Job ID R0023183 Date posted 09/22/2020 Location Lexington, Massachusetts

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Quality Disposition in our Lexington, MA office.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

POSITION OBJECTIVES:

This position has responsibility for performing Batch Disposition activities for Global API and US Drug Product, Finished Goods  in accordance with their Registered Approvals or Marketing Authorizations, their Manufacturing Authorizations, Takeda Global Quality Standards and Procedures, and the princilples and guidelines of current Good Manufacturing Practices.

POSITION ACCOUNTABILITIES:

  • Assists with the prioritization and coordination of batch release activities, to prevent supply disruption.
  • Review of batch record information from Contract Manufacturers/ Suppliers, and compilation of batch documentation for review according to Takeda requirements and SAP inspection plans.
  • Transfer needed information from Contract Manufacturers/ Suppliers batch documentation into Takeda systems e.g. LabLIMS and SAP/BPR
  • Prepare and review batch documentation for release, including upload of batch certificates to the repository.
  • Archive batch documentation according to Takeda and customer requirements.
  • Perform Technical Release of products in SAP/BPR based on release certificates from Contract Manufacturers/ Suppliers
  • Support other functions as needed with e.g. PQR preparation, deviations, change controls, and CAPA.
  • Maintenance of product lists and Quality relevant SAP master data.
  • Provides other support/input as needed to ensure the effective oversight of Contract Manufacturers/Suppliers and compliance of OncESSM procedure/processes with Takeda requirements, and GMP.

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

  • Bachelor's Degree in Pharmacy, Chemistry, Biology, or related discipline
  • Minimum 6 years of QA/QC experience in the pharmaceutical industry
  • Demonstrated teamwork, initiative, and problem-solving skills
  • Fluent in English language oral/written communication skills
  • Skills required:
    • Communication – ability to communicate ideas and data both verbally and written in a persuasive and appropriate manner.
    • Analytical Skills – ability to thoughtfully analyze a wide variety of information and data to make key decisions regarding potential risks associated with product quality or regulatory violations.
    • Teamwork – ability to establish professional relationships and rapport with internal and external peers and higher-level management
    • Proactiveness – ability to anticipate potential problems and risks related to commercial product operations, investigate solutions, and implement preventive actions.
    • Regulatory Understanding – broad  based knowledge of domestic and general knowledge of international regulations associated with manufacturing and packaging

Core Competencies / Skills

  • Critical Thinking
  • Digital and analytical skills
  • Investigation and problem solving
  • Good communication skills engaging stakeholders: site, business, network, company, regulators
  • Risk identification, evaluation and management
  • Continuous improvement

Leadership Behaviors

  • Enterprise thinking, finding innovative ways to improve compliance and process
  • Elevates capabilities of the organization

WHAT TAKEDA CAN OFFER YOU:

  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement Company match of charitable contributions
  • Health & Wellness programs including onsite flu shots and health screenings
  • Generous time off for vacation and the option to purchase additional vacation days
  • Community Outreach Programs

Empowering Our People to Shine

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Locations

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0023183

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