Career Opportunities with Seres Therapeutics, Inc.

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Careers At Seres Therapeutics, Inc.

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Associate Director, GxP Training and Document Control

Department: QA/QC
Location: Cambridge, MA

Why Seres Therapeutics

At Seres Therapeutics, we have a singular mission to transform the lives of patients by targeting the underlying cause of their diseases.  We are pioneers and explorers, charting a new course.  You’ll have the opportunity to truly define your area of focus.

If you have a pioneering spirit, join us as we ignite a revolution in the treatment of disease through the microbiome.

What’s Your Mission?

Reporting to the Sr. Director of Quality Assurance, you will be responsible for building and leading our GXP Training and Document Control functions.  In the near term, you will perform a needs assessment and work with QA Management to develop a strategy to ensure regulatory compliance, and align with business goals.  You will then design, build and implement training and document control programs to execute on that strategy. 

What You’ll Do

  • Develop, implement and lead site training system and procedure to assure compliance with regulatory requirements and internal policies
  • Develop and implement a standardized competency-based site Technical Training Program, working in conjunction with functional leaders and subject matter experts
  • Develop & implement measurement criteria, to assess effectiveness of training and learning, and report compliance metrics to both site and divisional levels
  • Develop, implement, and maintain applicable quality programs that support the documentation system and records retention system
  • Provide leadership in the selection and implementation of a Learning Management System (LMS)

What You’ll Bring

  • A minimum of 5 years, demonstrated experience in developing effective, performance-based on-the-job training and education programs
  • A minimum 5 years of experience in a GxP regulated environment including knowledge and experience with biotech/pharmaceutical regulatory expectations and inspections.
  • 3+ years’ experience with e-Learning content design, learning measurement and evaluation and implementation of LMS systems
  • Demonstrated experience effectively leading and developing teams
  • An understanding of document control processes

You May Also Bring

  • Clinical development experience

Who We Are

Seres Therapeutics is a clinical stage biotherapeutic company focused on discovering and developing Ecobiotic™ therapeutic products, novel drugs to treat important diseases by targeting the underlying biology of the human microbiome.  Founded by Flagship VentureLabs, Seres is pioneering the first therapeutics that catalyze a shift to health by augmenting the biology of the microbiome.  Current candidates span infectious, metabolic, and inflammatory diseases.  For more information, please visit http://serestherapeutics.com/

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