Director, Clinical Quality Assurance

Description

The Director of Clinical Quality Assurance (CQA) is a hands-on position responsible to ensure Pliant Therapeutics sponsored clinical trials adhered to applicable GCP regulations (e.g., FDA, ex-US, country-specific), ICH guidelines, Pliant Standard Operating Procedures (SOPs), and current industry standards and practices. The candidate will support clinical compliance and inspection readiness. This position will be reporting to the Senior Director, CQA.

The Director of CQA must thrive in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, effective, and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good negotiation skills, ability to analyze issues to support relevant and realistic plans, and support program recommendations. Demonstrated ability to support strategic and tactical decisions into action; excellent analytical skills, and to support plans to resolve issues and mitigate risks.

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

Responsibilities

• Represent clinical quality at the program team meetings and provide operational quality guidance to the development teams.
• Represent clinical quality at CROs operational meetings, service provider meetings, and service/vendor quality meetings.
• Provide quality oversight of the ongoing clinical programs, ensuring that the appropriate assessment and monitoring, risk assessment and risk mitigations are in place.
• Review clinical trial documentation for data integrity and compliance with Good Clinical Practice and regulations including key clinical and IND/NDA enabling documents.
• Provide clinical quality support for Health Authority Inspections, service providers and CROs operational meetings, as well as inspection readiness activities.
• 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.
• 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.
• Provide compliance advice and guidance to achieve continuous quality improvement and effective quality assurance and continue to foster Pliants’ culture of continuous improvement with emphasis on efficiency and effectiveness.
• Support the implementation of internal standards, policies, and procedures to ensure compliance, which includes Co-author and review Standard Operating Procedures.
• Develop and implement study specific audit plans and annual audit schedules and develop periodic compliance/metric reports.
• Support the selection of clinical service providers and qualification activities
• Support quality event management for assigned clinical programs and/or studies, including assessment of potential root causes and CAPA. Assist with the oversight of the completion of corrective and preventative actions (CAPA) upon audit completion.
• Responsible for GCP training to include development and revision of training matrices and training new GCP personnel.
• 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. This will include support of contract GXP auditors performing various GXP audit types.

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 with 12 years’ experience required or advanced degree in a scientific field with 10 years’ experience preferred. Quality assurance professional certification is a plus.
• At least 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 including understanding and application of domestic and international regulatory requirements.
• Previous experience of Good Clinical Practice (GCP), and Good Clinical Laboratory Practice (GCLP).
• Knowledge and experience implementing phase appropriate procedures and processes and familiarity with data integrity controls.
• Experience interacting with domestic and international clinical service providers for early phase to late-stage clinical trials.
• Proven history of industry success including experience in regulatory inspection preparation and supporting inspections.
• Experience with the audit process, auditing clinical sites, and auditing clinical service providers is preferred.
• Experience with Pre Approval Inspection readiness activities such as creating story boards, inspection electronic management systems, mock inspection, etc., including, clinical study site preparation.
• Clinical Quality Auditor certificate is a plus.
• Some travel may be required.
• Ability to operate in alignment with Pliant’s values and culture.

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 $230K – $240K. 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.