• Support managing a risk-based clinical Quality Management System (QMS) for GCP QA in compliance with applicable regulatory requirements (US and OUS), and company policies.
• Author and review Standard Operating Procedures through gap analysis.
• Continue to foster Plaints’ culture of continuous improvement with emphasis on efficiency and effectiveness.
• Achieve assigned deliverables of the Clinical QA function.
• Conduct or provide support of GCP, GCLP, GLP, and GVP audits of clinical investigator sites, Contract Research Organizations (CROs), contract clinical laboratories, and processes/systems to determine compliance status.
• Responsible for oversight of the completion of corrective and preventative actions (CAPA) upon audit completion.
• Responsible for implementation of internal standards, policies, and procedures to ensure compliance.
• Support contract GXP auditors performing various GXP audit types.
• Support development and implementation of audit plans and annual audit schedules.
• Provide compliance advice and guidance to achieve continuous quality improvement and effective quality assurance.
• Interface with Pliant functional areas, including regulatory affairs, and development operations, as appropriate, to provide guidance, interpretation, and information on regulations, standards, and quality systems.
• Support quality event management for assigned clinical programs and/or studies, including assessment of potential root causes and CAPA.
• Support the identification of GCP, GCLP, GLP, and GVP (as pertaining to conduct of clinical trials) compliance risk areas (internal and external) and support the resolution, development, and implementation of risk mitigation measures. Ensure compliance with Quality objectives, policies, and procedures.
• Responsible for GCP training to include development and revision of training matrices and training new GCP personnel.
• Responsible for TMF compliance oversight for all studies.
• Collaborate with Clinical Development (including PV/Safety), Regulatory Affairs, and Development Operations (including Clinical Operations, Data Management, and Biostatistics), CROs and clinical sites to support overall GCP compliance and inspection readiness.

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.

• Bachelor’s degree required, advanced degree in a scientific field preferred. Quality assurance professional certification is a plus.
• At least 10 years of experience in Clinical Quality Assurance.
• Broad knowledge of risk-based quality systems approaches consistent with ICH E6 (R2) and proposed (R3) for Good Clinical Practice. Experience with all phases of clinical trials.
• Knowledge and practical application of ICH E8 (R1)
• In-depth knowledge of and ability to interpret and apply GCP, EU, FDA, and ICH regulations and guidelines.
• Previous experience of Good Clinical Practice (GCP), Good Clinical Laboratory Practice (GCLP), Good Laboratory Practice (GLP), and Good Pharmacovigilance Practice (GVP).
• Strong analytic skills with practical knowledge of how to identify key performance quality metrics to set targets for maintaining a state of compliance while identifying areas for improvement.
• Experience with the audit process, auditing clinical sites, and auditing clinical service providers.
• Familiarity with data integrity controls, experience in system validation is a plus.
• Understanding and application of domestic and international regulatory requirements.
• Proven track record of industry success including experience in regulatory inspection preparation and supporting inspections.
• In-depth knowledge and experience implementing phase appropriate procedures and processes.
• Experience interacting with domestic and international clinical service providers for early phase to late-stage clinical trials.
• Clinical Quality Auditor certificate is a plus.

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 $220,000 – $230,000. 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.