Posted to MedZilla on 9/20/2017


Takeda Pharmaceuticals

US-MA, Associate Director, Quality Control 1701574-MZ


 
 

Are you looking for a patient-focused, innovation-driven company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as an Associate Director, Quality Controlin our Bostonoffice.

Takeda is a global, innovation-driven pharmaceutical leader with 30,000 professionals working together across more than 70 countries. We have an unwavering dedication to put patients first for more than 230 years while we live our values of Takeda-ism Integrity, Fairness, Honesty, and Perseverance. We are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine.

Watch our Medicine for the World video.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an
Associate Director working on the Quality Control team, you will be empowered to review and author protocol and reports that support regulatory activities. Takeda is a focused on the well-being of the patient and the Quality Control team is a critical component in ensuring we meet our mission.

The Quality Control team is responsible for providing and coordinating study executions for all late phase and/or commercial products managed by the Commercial Quality Organization.

The Associate Director of Quality Control will oversee service providers in accordance with quality agreements by setting timelines for testing and study execution

This team will also manage data review for all products managed by the Release/Stability Team and ensure data is reviewed in a timely manner for release, stability and/or regulatory submissions

The Associate Director of Quality will develop and/or refine the testing and data review programs to increase efficiency and serve as Commercial Quality Control representative to cross functional project teams

The Associate Director of Quality Control will oversee contract laboratory management, including primary contact with Contract Testing service providers, coordinating delivery of all GMP testing documentation and monitoring release and stability testing and documentation. The AD will also support new initiatives and process improvements

Technical reports and presentation of Change Controls as needed in addition to atypical Investigations and Annual Product Quality Review Testing sections for all products managed by the Commercial Quality Group are also managed by the AD, Quality Control

REQUIRED QUALIFICATIONS:

Bachelors or Master s Degree in any Life Sciences, minimum 10+ years of biopharmaceutical experience

Previous industry experience in a regulated environment highly desirable

Minimum 7 years of direct managerial experience

Knowledge of cGMP regulations for US, Japan, EU and other markets

PREFERRED QUALIFICATIONS:

Desire to put people first and demonstrate the values of Takeda-ism

WHAT TAKEDA CAN OFFER YOU:


To further support and inspire our employees, our benefits include:

  • Home office with laptop
  • Company Vehicle
  • Comprehensive Benefits: Medical, dental, vision and prescription drug plans to choose from
  • 401k % match and pension plan
  • Educational assistance
  • Comprehensive career development

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Empowering Our People to Shine
takedajobs.com

Takeda is an EEO employer of minorities, women, disabled, protected veterans. For more information, visithttp://www.takeda.us/careers/EEO_Policy_Statement.aspx


Schedule
Full-time

Please visit our website at takedajobs.com

 
 


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