- 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.
- Bachelor degree in a scientific or technical discipline.
- A minimum of 8 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.).
- Good knowledge of Computer System Validation.
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Associate Director, Clinical Quality Assurance - Redwood City, United States - Third Rock Ventures
Description
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit high-value frontier targets in RAS-addicted cancers.
The company's R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies.
As a new member of the Revolution Medicines team, you will join other outstanding scientists in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
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.
Responsibilities:
Required Skills, Experience and Education:
Preferred Skills, Experience and Education:
An individual's position within the range may be influenced by multiple factors, including skills and experience in role, overall performance, individual impact and contributions, tenure, and market dynamics.
Base salary 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.
Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition and veteran status.
Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone.
We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy.
For additional information, please contact
