Associate Director, Clinical Quality Assurance

Revolution Medicines•Redwood City, CA

2d•Onsite

About The Position

Revolution Medicines is seeking an Associate Director, Clinical Quality Assurance, who will play a key role within Quality Assurance and is responsible for providing leadership and compliance support for RevMed sponsored clinical trials with respect to RevMed’s Standard Operating Procedures, applicable regulatory requirements (FDA, EU, ICH & country-specific), and current industry standards and practices. Support the development and maintenance of applicable Quality Systems and procedures that comply with applicable GCP standards and guidelines. Collaborate with clinical functions (e.g., Clinical Operations, Clinical Development) to provide GCP compliance support. Participate in clinical study execution teams (CSETs) to enable risk-based quality management and a culture of quality and open dialogue. Perform quality review of clinical trial documents with a focus on compliance / regulatory requirements and risk management. Collaborate with internal stakeholders, external auditors, and auditees to support the planning, preparation, conduct, reporting, and closure of GCP audits. Provide risk-based quality oversight for clinical trial activities and perform routine clinical vendor assessments. Provide support for Inspection Readiness activities (e.g., TMF activities, study documentation). Assess and coordinate activities relevant to potential quality issues associated with GCP and clinical trial conduct including but not limited to investigations, and root cause analysis, CAPA planning and management. Escalate identified issues to QA Management and other relevant leadership as needed in a timely manner. Enable other assigned GCP or GXP related tasks, as appropriate. Support GCP audits and inspections of RevMed, Vendors, and clinical investigator sites by regulatory authorities or business partners. Build positive professional relationships and trust to support learning, respect, open communication, collaboration, and teamwork.

Requirements

Bachelor’s degree in scientific or technical discipline.
A minimum of 10+ years of experience in GCP Quality in the pharmaceutical or biotechnology industry.
8 years in any of the following areas: audit or audit management experience, inspection readiness, Deviation/CAPA management, or related quality management system responsibilities.
Extensive knowledge of ICH GCP, other relevant ICH guidelines and regulatory requirements (minimally US FDA) regarding applicable drug development regulations.
Effective communication (verbal and written).
Ability to build and sustain positive relationships with GxP colleagues, internal stakeholders, and external partners.
Ability to create innovative solutions to problems, while integrating stakeholder input and feedback.
Ability to critically evaluate and troubleshoot complex problems with diligence.
Ability to manage multiple priorities and aggressive timelines.
Highly responsible, self-motivated professional with enthusiasm and passion for the work.
Highly proficient with various Microsoft and other computerized systems (e.g., Word, Outlook, Excel, PowerPoint, Visio, etc.).

Nice To Haves

Good knowledge of Computer System Validation.

Responsibilities

Providing leadership and compliance support for RevMed sponsored clinical trials with respect to RevMed’s Standard Operating Procedures, applicable regulatory requirements (FDA, EU, ICH & country-specific), and current industry standards and practices.
Support the development and maintenance of applicable Quality Systems and procedures that comply with applicable GCP standards and guidelines.
Collaborate with clinical functions (e.g., Clinical Operations, Clinical Development) to provide GCP compliance support.
Participate in clinical study execution teams (CSETs) to enable risk-based quality management and a culture of quality and open dialogue.
Perform quality review of clinical trial documents with a focus on compliance / regulatory requirements and risk management.
Collaborate with internal stakeholders, external auditors, and auditees to support the planning, preparation, conduct, reporting, and closure of GCP audits.
Provide risk-based quality oversight for clinical trial activities and perform routine clinical vendor assessments.
Provide support for Inspection Readiness activities (e.g., TMF activities, study documentation).
Assess and coordinate activities relevant to potential quality issues associated with GCP and clinical trial conduct including but not limited to investigations, and root cause analysis, CAPA planning and management.
Escalate identified issues to QA Management and other relevant leadership as needed in a timely manner.
Enable other assigned GCP or GXP related tasks, as appropriate.
Support GCP audits and inspections of RevMed, Vendors, and clinical investigator sites by regulatory authorities or business partners.
Build positive professional relationships and trust to support learning, respect, open communication, collaboration, and teamwork.