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Contract Document Control and Training Management

South San Francisco, CA

Pliant is a late-stage biopharmaceutical company focused on the discovery, development and commercialization of novel and potential first-in-class and next-in-class therapeutics for the treatment of fibrotic lung diseases. As the leader in integrin biology and with our deep understanding of fibrosis biology, we’re developing small molecule drug candidates designed to efficiently block a well-established route of fibrosis. 

We are driven by scientific innovation and committed to empowering patients and our employees. We recognize that our employees’ dedication and individual contributions are key to achieving our mission of bringing best-in-class inhibitors of fibrotic diseases to people in need. We offer a culture that encourages creativity and celebrates diverse backgrounds and viewpoints.

We are seeking passionate and compassionate individuals to join our team and to make a difference in the lives of patients.

Description

Pliant Therapeutics is currently seeking experienced document control operations team-member to join our team as Manager, Document Control and Training Manager.  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 use Veeva QualityDocs to manage multiple cross-departmental document workflows, training requirements, and assignments, each with distinct timelines and deliverables, develop and conduct training on Veeva, process documents in Word to align with Pliant standards, communicate clearly (in verbal and written form), and display exemplary organizational skills.  This position will require the ability to manage both paper-based and electronic document and training processes utilizing Veeva QualityDocs. 

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

Responsibilities

  • Manage Document Control, including the administration of the Veeva QualityDocs and all aspects of GxP controlled documents by independently prioritize and execute day-to-day operations management of the electronic document/training management system including:
    • New user and advanced user training on Veeva QualityDocs
    • Manage the Document Change Control process for new documents, revisions and supporting partner groups with document management through the controlled document flow (creating, editing, reviewing, and approval lifecycles) in addition to management of periodic document review
    • Identify potential system enhancements, troubleshoot and investigate issues to ensure comprehensive and timely resolution
    • Create and provide key performance and key quality metrics to senior management as needed
    • Lead the design, development and implementation of lifecycles and workflows for business processes with cross-functional departments to assess effectiveness of current systems and make plans for improvements, to ensure the alignment of processes for a cohesive system configuration
  • Create and revise system training materials and procedures and administer user training.
  • Lead onsite and offsite records archival
  • Support testing and reporting for change control verifications to Veeva QualityDocs
  • Administer core training management activities with Vault Training, including creation and assignment of roles, curricula, and training requirements for controlled documents
  • Provide routine reports on controlled document progression timing and training assignment completion and escalate as needed

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.

  • 6+ years’ experience in a Quality Assurance document control role, with 2-5 years using Veeva QualityDocs, including workflow management and reporting
  • Strong proficiency in Microsoft Word, including formatting, template design and management, and document field formulas
  • Experience in file organization, including supporting file retrieval and distribution with tracking
  • Scheduling, tracking, and reporting metrics for periodic reviews of controlled documents support managing multiple workstreams
  • Training new users on existing processes and developing, revising, and presenting training to experienced users on new and updated processes

The hourly rate for this role is $85/hr – $86/hr. Individual pay may vary based on additional factors, including, and without limitation job-related skills, experience, work location and relevant education or training. Pliant’s compensation package also includes benefits, equity, and annual target bonus for fulltime positions.

 

To understand how Pliant complies with and manages your personal information with respect to the California Consumer Privacy Act, please visit https://pliantrx.com/ccpa-applicant-and-staff-privacy-notice/. 

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