Demo

Director, Document and Training Management

Tbwa Chiat/Day Inc
San Francisco, CA Full Time
POSTED ON 4/17/2025
AVAILABLE BEFORE 5/17/2025

Director, Document and Training Management

Pliant Therapeutics is a late-stage biopharmaceutical company focused on the discovery and development of novel therapies for fibrotic diseases. Founded by Third Rock Ventures with world-renowned academic thought leaders, Pliant is raising the bar to meet the unmet medical needs of physicians, patients and families impacted by fibrotic diseases.

Find out more about the daily tasks, overall responsibilities, and required experience for this opportunity by scrolling down now.

Pliant is currently seeking a seasoned industry leader to join our team as Director, Document and Training Management. This role will provide strong leadership and strategic planning in support of client functions within the organization.

To be successful in this role, you must be able to establish vision and guidance to the GxP personnel, communicate clearly (in verbal and written form), and display exemplary organizational / leadership skills. This will require the ability to develop and administer quality systems in regard to document management and personnel training and qualification, including electronic quality system processes utilizing phase appropriate principles.

This is a hybrid position, requiring 3 days / week at Pliant (South San Francisco).

Responsibilities

  • Responsible for direction and control of the site Document Management quality system, including Veeva document management (in Veeva QualityDocs and hard copy) program, processes, procedures, system administration and training.
  • Collaborate cross functionally to implement, oversee, and improve workflows for document management and personnel training.
  • Set, track, and trend site related Quality Metrics.
  • Business Process Owner for Veeva QualityDocs to drive quality improvements by designing, supporting, and improving GxP documentation management.
  • Responsible for implementation and ownership of the site GxP training program (in Veeva Vault), processes, procedures, system administration and training.
  • Refinement and execution of the personnel training and qualification program, including the support of functional areas in designing and execution of training.
  • Supporting ongoing implementation and improvement of the training assessment process and requirements.
  • Supporting site inspection readiness program.
  • Other duties as assigned.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, abilities, and prior experience required.

  • Minimum 12 years of relevant industry experience, ideally in all clinical phases through commercialization and a degree in pertinent life sciences.
  • Experience in managing GxP document management and training systems.
  • Strong knowledge of cGMP / ICH / FDA / EU requirements.
  • Strong understanding of ICH, FDA, and EU regulations.
  • Exercise sound judgement in ensuring that written procedures are followed with proven ability in driving quality process improvement initiatives.
  • Independently motivated, detail oriented and good problem-solving ability.
  • Excellent communication skills, both oral and written.
  • Excellent interpersonal skills and ability to effectively collaborate in a dynamic project team environment.
  • Proficient computer skills required with experience using Microsoft Word, Excel, and PowerPoint.
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