The Opportunity:

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.

Required Skills, Experience and Education:

• 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.).

Preferred Skills:

• Good knowledge of Computer System Validation.
  #LI-Hybrid #LI-JC1

The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.

Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.

Base Pay Salary Range

$186,000-$233,000 USD

We are aware of recent recruitment scams in which individuals or organizations falsely represent themselves as being affiliated with Revolution Medicines. These scams may appear as false job advertisements or unsolicited contacts through communication or chat platforms, email, phone, or text message.

Please note that Revolution Medicines does not extend unsolicited employment offers and will never ask candidates to provide financial information, purchase equipment, or pay fees as part of the hiring process. All legitimate communication from Revolution Medicines will come from an official @revmed.com email address.

If you believe you've been contacted by someone impersonating a Revolution Medicines recruiter, please report it to [email protected] so we can share these impersonations with our IT team for tracking and awareness.