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Clinical Quality Assurance Director

2 months ago

South San Francisco, California, United States Pliant Therapeutics Full time
About the Role

We are seeking a highly skilled Clinical Quality Assurance Director to join our team at Pliant Therapeutics. As a key member of our Clinical Quality Assurance department, you will play a critical role in ensuring the quality and integrity of our clinical trials.

Key Responsibilities
  • Represent clinical quality at program team meetings and provide operational quality guidance to development teams.
  • Participate in CROs operational meetings, service provider meetings, and vendor quality meetings.
  • Provide quality oversight for ongoing clinical programs, ensuring appropriate assessment, monitoring, risk assessment, and risk mitigation.
  • Review clinical trial documentation for data integrity and compliance with Good Clinical Practice and regulations.
  • Support Health Authority Inspections, service providers, CROs operational meetings, and inspection readiness activities.
  • Collaborate with Clinical Development, Regulatory Affairs, Development Operations, CROs, and clinical sites to support overall GCP compliance and inspection readiness.
  • Manage a risk-based clinical Quality Management System (QMS) for GCP QA in compliance with applicable regulatory requirements and company policies.
  • Provide compliance advice and guidance to achieve continuous quality improvement and effective quality assurance.
  • Support the implementation of internal standards, policies, and procedures to ensure compliance.
  • Develop and implement study-specific audit plans, annual audit schedules, and periodic compliance/metric reports.
  • Assist in selecting clinical service providers and conducting qualification activities.
  • Manage quality event management for assigned clinical programs and studies.
  • Oversee GCP training and conduct or support GCP, GCLP, GLP, and GVP audits of clinical investigator sites, CROs, contract clinical laboratories, and processes/systems.
Requirements
  • A Bachelor's degree with 12 years of experience, or an advanced degree in a scientific field with 10 years of experience.
  • A minimum of 5 years of experience in Clinical Quality Assurance or Clinical Operations.
  • Broad knowledge of risk-based quality systems approaches consistent with ICH E6 (R2) for Good Clinical Practice.
  • Experience with all phases of clinical trials.
  • Knowledge and practical application of ICH E8 (R1).
  • Ability to interpret and apply GCP, EU, FDA, and ICH regulations and guidelines.
  • Experience with Good Clinical Practice (GCP) and Good Clinical Laboratory Practice (GCLP).
  • Familiarity with phase-appropriate procedures, processes, and data integrity controls.
  • Experience interacting with domestic and international clinical service providers for early to late-stage clinical trials.
  • Proven industry success, including experience in regulatory inspection preparation and supporting inspections.
  • Experience with the audit process, including auditing clinical sites and clinical service providers.
  • Clinical Quality Auditor certification is a plus.
  • Some travel may be required.
What We Offer

We offer a competitive pay rate of $ Per hour, as well as benefits, equity, and an annual target bonus for full-time positions. If you are a motivated and experienced Clinical Quality Assurance professional looking for a new challenge, please submit your application.