Description

Pliant Therapeutics is currently seeking a seasoned industry leader to join our team as Sr Director Quality Systems and Compliance. 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 Quality personnel, communicate clearly (in verbal and written form), and display exemplary organizational / leadership skills. This will require the ability to develop and deploy both paper and electronic quality system processes utilizing phase appropriate principles. In addition, the successful candidate will create an environment in which the team is highly motivated and engaged to work collaboratively within their team and cross functionally to deliver exceptional results and ensure long-term success.

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

Responsibilities

• Strong knowledge of cGMP/ICH/FDA/EU requirements. Ability to assess compliance of regulations and industry standards.
• Responsible for implementation and ownership of the site Quality Systems program, processes, procedures, system administration and training.
  • Collaborate cross functionally to define workflows for Change Control, CAPA, Deviation.
  • Establish site Document Control and Management processes through Veeva QualityDocs including storage and archival.
  • Establish site Training Program including curricula, metrics and monitoring.
  • Responsible for setting, tracking, and trending of site Quality Metrics.
  • Responsible for leading and facilitating Quality Management Review to drive quality improvements by leveraging detailed data review as well as identification of action items.
  • Establish Quality Risk Management process and site Risk Register.
  • Establish Complaints and Recalls program.
  • Develop Site Master File by template and collaborate with cross functional partners to drive content.
• Responsible for implementation and ownership of the site Quality Compliance program, processes, procedures, system administration and training including:
  • Establishment and successful implementation of the Supplier Quality Program with development and successful execution of the audit qualification and audit program.
  • Internal audit program including evaluation of phase appropriate audit requirements.
  • Development of site inspection readiness program and coordination of site regulatory strategy and inspection support.
• Responsible for Quality Assurance Validation support of IT generated CSV projects.
• 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.

• BA/BS degree in pertinent life sciences.
• Minimum 15+ years of relevant industry experience, ideally in all clinical phases through commercialization.
• Experience in running front and back rooms for agency inspections and setting up Inspection readiness programs.
• 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 to clearly and concisely communicate with internal and external team members.
• 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.
• Veeva experience preferred.

Pliant requires all new hires to be fully vaccinated prior to the first date of employment (subject to any legally required exemptions).

The annual base salary for this role is $255K – $265K. 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.