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Quality Manager, Pharmaceutical Sciences & Device Quality Operations

Boston, 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 2021.

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

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Quality Manager, Pharmaceutical Sciences & Device Quality Operations

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Job ID R0029658 Date posted 02/26/2021 Location Boston, Massachusetts

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda.  Join us as a Quality Manager Pharmaceutical Sciences & Device Quality Operations in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Quality Manager working on the R&D Quality team, you will be empowered to coordinate the execution of the overall implementation and management of GMP supplier quality strategy and processes for the Pharmaceutical Sciences & Device Quality organization. A typical day will include: 

  • Collaborate effectively with internal Takeda stakeholders (e.g., Pharmaceutical Sciences, Clinical Supply Chain, Procurement, Global Quality Auditing & Supplier Management) to manage the qualification of GMP suppliers.

  • Support the supplier identification and site selection process, Quality due diligence activities, establish supplier risk assessments and facilitate new supplier qualification requests.

  • Manage the R&D GMP Quality Management Lifecycle processes for qualification and maintenance of suppliers to ensure compliance. Processes include but not limited to Quality audits, Quality Agreements, notifications of change and supplier quality performance metrics.

  • Support development and execution of supply chain compliance and control strategies.

  • Manage the non-medical product complaint process to ensure product complaints pertaining to clinical trial material are received, investigated, closed, and tracked/trended in compliance with cGMP and Takeda requirements

  • Support the compliance and execution of the Stock Recovery Process utilized for the removal, recovery, or correction of Takeda’s clinical trial materials when and if determined necessary

  • Lead and implement critical projects which enhance Pharmaceutical Sciences & Device Quality’s efficiencies and innovation

  • Additional duties as assigned

Technical/Functional (Line) Expertise

  • Working knowledge of current Good Manufacturing Practice requirements for the biopharmaceutical and medical device industries

  • Experience in supplier quality management and auditing GMP suppliers (e.g., CMOs)

  • Experience with risk management strategies and general project management

  • Proven success in identifying and implementing continuous improvement initiatives

  • Proficient in analyzing data to identify performance trends

  • Ability to proactively manage the development and re-engineering of key processes and systems in support of the business’s mission

Leadership

  • Demonstrated teamwork, initiative, and problem-solving skills

  • Clear, concise and consistent in written and verbal communications

  • High attention to detail

Decision-making and Autonomy

  • Independently manages projects, carries out root-cause investigations, analyzes data and makes recommendations to management

Interaction

  • Experience working within complex/matrixed organizations

  • Demonstrated ability to collaborate with and achieve results through others, the ability to build strong and sustainable relationships and the capability to interact within all levels of the organization

Innovation

  • Ability to read, analyze and interpret common scientific and technical data/reports and legal/regulatory documents

  • Effectively presents information to management, internal groups and stakeholders

Complexity

  • Analytical capabilities with the ability to analyze a wide variety of information and data to determine potential risks

  • Ability to anticipate potential problems and risks related to quality expectations and regulatory compliance, formulate action plans, and implement solutions

  • Ability to work effectively in a fast paced, rapidly changing environment and to work on multiple work streams and projects simultaneously

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:(List the essential and desirable education and competency requirements to perform the primary responsibilities of the job.  Any minimum requirements should be noted.)

  • Bachelor’s Degree in Chemistry, Biology, Engineering or related field

  • Minimum of 6 years professional working experience in the field of healthcare products or related activities such as pharmaceutical or device manufacturing, Quality Control or Quality Assurance including at least 4 years in GMP Quality or Compliance

  • Six sigma/lean processing, project management professional and/or auditor certification preferred

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

  • Learn more at takedajobs.com

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0029658
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