Skip to main content

Search Our Jobs

Sr Mgr Quality Assurance Cell Therapy

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.

Back to Job Navigation (Overview)

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

Back to Job Navigation (Success)

Back to Job Navigation (Life at Takeda)

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.

Back to Job Navigation (Rewards)

Sr Mgr Quality Assurance Cell Therapy

Apply Now
Job ID R0025908 Date posted 02/25/2021 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

Objectives

  • The Sr. Manager, Advanced Therapies QA is responsible for developing and executing quality strategies for external supply chains of clinical-phase cell therapy programs.
  • This position directly manages the development, implementation, and maintenance of cGMP and associated regulated quality processes for clinical-phase cell therapies.
  • This position is responsible for Quality leadership for external partnership programs.
  • The Sr. Manager, Advanced Therapies QA ensures execution of continuous improvement through idea development, plan creation, implementation, and championing project management methodology for projects of high complexity and risk.

Accountabilities

  • Provide Quality leadership for responsible programs/ projects in terms of phase-appropriate science-based perspectives in the cross-functional team.
  • Develop and implement strategic approach for qualification/improvement of the critical material supplier’s capability including academia (e.g. virus vector, protein, antibody, plasmid, gRNA) to ensure final product quality and build in the material control strategy.
  • Serve as a qualified lead auditor for the supply chains in the implementation of the strategy, qualify the suppliers and develop Quality Agreement per Takeda procedures.
  • Develop and manage the product Quality infrastructure (e.g. SOPs, training) necessary to oversight Takeda’s external supply chains of clinical-phase cell therapies.
  • Interact with and influence outsourced-based vendor personnel in execution of strategy and identification of continuous improvement opportunities which ensure Takeda quality expectations, minimize compliance risk, and uphold cGMP compliance.
  • Ensure clinical trial sponsor responsibilities are fulfilled to ensure compliant disposition of cell therapy products for use in Takeda clinical studies.
  • Responsible for batch disposition for the critical materials supplied from external vendors for clinical-phase cell therapies.
  • Maintain knowledge of global regulatory requirements for cell therapy products and ensure compliance.
  • Develop solutions to complex Quality issues which potentially impact cell therapy manufacturing and testing to ensure patient safety, as well as compliance with cGMP regulations and Takeda quality expectations.
  • Provide leadership to ensure timely, well-documented, and compliant resolution of quality investigations and implementation of corrective actions that maintain a continual state of regulatory compliance for Takeda’s pharmaceutical development activities and GMP operations in cell therapies.
  • Additional duties as assigned.

Education, Behavioral Competencies & Skills

  • Bachelor’s Degree in Chemistry, Biology, Engineering or related field. Masters preferred.
  • Minimum of 10 years of increasing responsibility and experience in the global pharmaceutical industry. At least 3 years of managerial experience.
  • Minimum of 7 years of Quality/cGMP Compliance experience.
  • Specific experience in one or more of the following: cell and/or gene therapy product manufacturing or testing, pharmaceutical development, investigational medicinal products, advanced therapy medicinal products.
  • Experience working in an internal biopharmaceutical development/production environment.
  • Understanding and working knowledge of Quality Management Systems, ability to interpret requirements, anticipate issues, make informed decisions and respond rapidly to emerging quality situations.
  • Experience serving as qualified lead auditor for cGMP compliance including aseptic manufacturing for minimum 3 years.
  • Demonstrated knowledge of current international regulations and guidance associated with cell therapy, gene therapy, etc.
  • Experience in regulatory agency inspection conduct and management, action planning and responses.
  • Demonstrates ability to independently distinguish between criticalities of quality issues and identify issues or topics for management escalation independently. Able to clearly articulate issues in a timely manner.
  • Demonstrates and actively seeks to establish professional relationships and rapport with internal and external peers and higher-level management. Experience working on teams in a complex, matrixed and global environment. Proactive leadership of quality topic discussions.

This job posting excludes CO applicants

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0025908
Apply NowEmail Me

Back to Job Navigation (Responsibilities)

Explore the Area

Check out where you could be
working if you apply.

View Map