Director, Quality Systems and Compliance
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. As the leader in the discovery and development of novel therapeutics for the treatment of fibrotic diseases, Pliant is developing small molecule drug candidates specifically designed to impact the fibrotic process.
The Company’s lead product candidate, bexotegrast (PLN-74809), is an oral small molecule, selective inhibitor of the αvβ1 and αvβ6 integrins that play a key role in multiple fibrotic pathways. Bexotegrast has received Fast Track Designation and Orphan Drug Designation from the U.S. Food and Drug Administration for both idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC) and Orphan Drug Designation from the European Medicines Agency in IPF and PSC. Pliant is currently conducting BEACON-IPF, a Phase 2b/3 trial of bexotegrast for the treatment of IPF.
Pliant is conducting a Phase 1 study for its third clinical program, PLN-101095, a small molecule, dual-selective inhibitor of αvß8 and αvß1 integrins, that is being developed for the treatment of solid tumors. The Company also has discovery and development programs in oncology and muscular dystrophies.
Description
Pliant Therapeutics is currently seeking a seasoned industry leader to join our team as 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. Addtionally, 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 preferred hybrid position, requiring 3 days/week at Pliant (South San Francisco).
Responsibilities
- Responsible for direction and control of the site Quality Systems program, processes, procedures, system administration and training.
- Collaborate cross functionally to implement, oversee, and improve workflows for Change Control, CAPA, Deviation, and Product Complaints, including support and approval of robust root cause and impact investigations and resolution.
- Set, track, and trend site Quality Metrics.
- Primary Contributor to Quality Management Review to drive quality improvements by leveraging detailed data review as well as identification of action items.
- Implement and support Quality Risk Management process; drive and maintain site Risk Register.
- Implement and manage Clinical product retrieval and recalls program.
- Maintain 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:
- Execution of the Supplier Quality Program, including the audit qualification and audit program, as well as establishing, monitoring, and reporting of supplier key performance indicators.
- Execution of the Internal audit program including evaluation of phase appropriate audit requirements.
- Drive and report site and contract service provider inspection readiness program, as well as site regulatory strategy and inspection management.
- Oversight and management of the QA Validation role and personnel to provide quality oversight, review and approval of all internal computer system validation initiatives.
- 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.
- Strong knowledge of cGMP/ICH/FDA/EU requirements. Ability to assess compliance of regulations and industry standards, including phase appropriate controls and readiness for commercialization.
- Minimum 12+ years of relevant industry experience, ideally in all clinical phases through commercialization and a degree in pertinent life sciences
- 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
The annual base salary for this role is $215K – $225K. 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/.
