Director, Quality Assurance

Pliant Therapeutics is a clinical 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 for progress to meet unmet medical needs for patients and physicians.  The company’s focus is on mechanism-based intervention in the fibrotic process using small molecules. The company’s lead product candidate, PLN-74809, is designed to be a selective inhibitor of αvβ1 and αvβ6 integrins that play a key role in multiple fibrotic pathways. PLN-74809 has received Orphan Drug Designation from the U.S. Food and Drug Administration in both idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC), has completed Phase 1b testing. Pliant’s second product candidate, PLN-1474, is designed to be an oral, small molecule selective inhibitor of αvβ1, targeting late-stage liver fibrosis and is partnered with Novartis.   The Company is seeking passionate, creative and dedicated individuals to join our team and contribute to our mission.

Description

This is an exceptional opportunity to establish the Quality Systems and implement a Quality Assurance Operations function in a dynamic start-up company driven by a leadership team of proven drug developers.

The ideal candidate will have extensive experience leading GXP Quality Assurance activities and deep understanding and demonstrated working knowledge of Code of Federal Regulations (CFRs), ICH guidance documents, and other regulations that govern GXP compliance during clinical development and commercialization of drug candidates. Quality Assurance will be accountable for all aspects of product quality throughout development, both internally and in collaboration with contract manufacturers and testing laboratories. The ideal candidate will have a proven track record of providing quality assurance support for regulatory submissions of CMC sections resulting in world-wide marketing approvals for drug products.

Essential Functions

 

  • Responsible for Quality Assurance Operations and Quality Systems at Pliant
  • Oversee the creation and implementation of the Policies and SOPs constituting the Pliant Quality System
  • Create and/or update the Pliant Quality Manual
  • Recruit and develop Quality Assurance team members
  • Review and approve Master Manufacturing Batch Records, Packaging Specifications, Product Specifications, Analytical Methods, Stability Protocols/Reports, and Validation Protocols/Reports
  • Review executed Manufacturing Batch Records and disposition GMP drug substance and drug product batches for use in clinical trials
  • Conduct training on GxP Compliance and Pliant Quality Systems
  • Establish and maintain the systems for change control, deviations/investigations, and CAPAs
  • Manage and trend product complaints
  • Establish and maintain a program for internal quality audits and quality audits of GMP vendors
  • Develop, track, and report key quality metrics to senior management
  • Establish and maintain quality agreements with vendors of GXP products and services
  • Oversee external contractors/consultants providing GCP oversight to Pliant clinical trials
  • Collaborate with Clinical Supply Chain to manage the QP release of investigational medicinal product lots

 

Requirements

 

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, and/or ability required.

  • Experience with Batch Disposition at all phases of clinical development
  • Direct experience hosting third-party audits and/or inspections by FDA or other regulatory authorities
  • Experienced in the oversight of quality activities at contract manufacturing and testing organizations
  • Auditor training or certification desirable
  • Skilled at preparing, negotiating and managing phase-appropriate quality agreements with Pliant GxP vendors
  • Effective organizational traits with demonstrated project management, leadership, stakeholder management and influencing skills
  • Comprehensive knowledge of regulations, guidance documents, and industry standards/best practices related to Quality Systems and GxP Compliance
  • Ability to travel up to 10% of the time

Preferred Education/Experience:

  • Bachelors degree in chemistry, pharmaceutical sciences, or related scientific discipline
  • Minimum of 12 years of pharmaceutical development /manufacturing experience with at least 8 years experience with increasing responsibility in a GxP quality function in the pharmaceutical or biotechnology industry
  • Prior experience in a Quality Control or Manufacturing role desirable
  • ASQ certification is desirable

Knowledge, Skills and Abilities:

  • Small company / pre-commercial stage company experience desirable
  • Strong collaboration and cross-functional team participation skills
  • Preference for applying a solutions-oriented mindset and approach to resolving complex quality issues
  • Effective leader of others and ability to mentor/develop team members
  • High self-awareness and commitment to iterative learning and development
  • Effective communicator, verbal and written, strong interpersonal skills
  • Accuracy and attention to details