Career Opportunities with Seres Therapeutics, Inc.

A great place to work.

Careers At Seres Therapeutics, Inc.

Even if you don’t see a job that’s a fit, but you’re excited by what Seres is doing and want to be a part of it, we’d appreciate hearing from you and will keep you in mind for a future opportunity. Click here to submit your resume. 


Director, GxP Training and Document Control

Department: Medical
Location: Cambridge, MA

Director, GxP Training and Document Control

Develops, directs and leads the GXP training and Document Control functions with the Seres QA Shared Services group. This position is responsible for working with management to develop the Training and Document Management Program including: creation and implementation of training processes to ensure regulatory compliance, high performance on-the- job training, document control records management processes, and business objectives achievement.

 

Key Responsibilities:

  • Design, develop and implement training and education strategies to continuously improve training effectiveness, standardize and harmonize processes to align with Seres strategy.
  • 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.
  • Implement and oversee GxP New Hire and ongoing refresher training.
  • Partner with supervisors and managers to develop and assure curricula are in place for all employees.
  • Develop & implement measurement criteria, to assess effectiveness of training and learning, and report compliance metrics to both site and divisional levels.
  • Ensure documentation practices and systems are in place to monitor and maintain training requirements, history and qualifications.
  • Develop and implement quality standards (or trainer qualification requirements) for internal and external trainers
  • Develop, implement, and maintain applicable quality programs that support the documentation system and records retention system
  • Support day to day operations as the process owner for programs such as Good Documentation
  • Practices, Document Periodic Review, etc.
  • Provide Quality leadership as Quality liaison to IT for computer system assessments, validation and change control for document management and Learning Management systems.
  • Establish key performance indicators (KPI), maintain, and report applicable department or organizational metrics.

Qualifications:

  • Bachelor's degree in Education, Life Sciences, Engineering or Business. Advanced degree in Education preferred (M.Sc., Ph.D., etc.).
  • Minimum of 10 years of training/education/document control experience, minimum 5 years of experience in a GxP regulated environment including knowledge and experience with biotech/pharmaceutical regulatory expectations and inspections.
  • Minimum of 5 years’ leadership experience and demonstrated success in developing effective, competency-based technical training and education programs and platforms.
  • 3+ years’ experience with e-Learning content design and 5 of years’ experience in learning measurement and evaluation

Applicant Tracking System Powered by ClearCompany HRM Applicant Tracking System