Senior QA Specialist, Quality Systems, GxP Training
Redwood City, California, United States · Hybrid
$90k–$108k/yr
Senior
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress dive…
Senior QA Specialist, Global Document Control Management
Redwood City, California, United States · Hybrid
$90k–$108k/yr
Senior
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress dive…
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$90k–$108k/yr
Full-time
bachelor degree
Cash Compensation, Equity Awards, Learning And Development Opportunities
Posted 8d ago
~40 hrs/week
Responsibilities
Support and enhance the GxP Training Program by designing curricula and learning strategies to meet global regulatory requirements. Partner cross-functionally to manage training administration, evaluate program effectiveness, and maintain Quality Systems SOPs.
Requirements
Requires a BA/BS in Biological Sciences, Chemistry, or a related field with at least 5 years of Pharma/Biotech QA experience in a GxP environment. Proficiency with Veeva QualitySuite and a strong understanding of ICH guidelines are essential.
Full job description
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
The Opportunity:
Support the continuous enhancement of the GxP Training Program within the Quality Systems function, ensuring training processes, curricula, and learning strategies meet business objectives and global regulatory requirements.
Serve as the Quality Systems subject matter expert for GxP training, partnering cross-functionally with stakeholders to assess training needs, evaluate program effectiveness, and drive continuous improvement initiatives that strengthen compliance and operational excellence.
Design, develop, and maintain the instructor-led and web-based GxP training curricula using GxP learning principles and instructional design methodologies to support onboarding, role-based qualification, and continuing education programs.
Collaborate with functional leaders and SMEs to create engaging classroom training materials, eLearning content, facilitator guides, assessments, and blended learning solutions aligned with GxP requirements and job-specific competencies.
Execution and administration of companywide GxP training programs, ensuring training assignments, curricula, and qualification requirements are aligned with job descriptions, procedural changes, and regulatory expectations.
Evaluate the effectiveness of training programs through metrics, learner feedback, compliance trends, and quality data analysis; recommend and implement improvements to enhance learning outcomes and inspection readiness.
Develop and implement scalable Quality Systems processes, strategies, SOPs, and Work Instructions related to GxP training management and electronic Quality Management Systems (eQMS).
Drive a culture of quality, compliance, and continuous learning by influencing stakeholders, facilitating knowledge sharing, and promoting best practices in training and instructional design across the organization.
Support cross-functional initiatives related to training process optimization, learning technologies, and quality system improvements without direct people management responsibilities.
Required Skills, Experience and Education:
BA/BS degree in Biological Sciences, Chemistry, or related field and/or equivalent experience and education.
Minimum 5+ years of Pharma/Biotech industry experience in Quality Assurance (QA) in a GxP environment.
Experience in developing and implementing GxP quality systems to meet current regulatory and industry standards.
Direct experience managing GxP document management and training systems.
Excellent working knowledge and understanding of GxP requirements, proficiency in applying regulatory requirements and ICH guidelines.
Direct experience working with Veeva QualitySuite electronic platforms (QualityDocs, Training, QMS).
Proficient with Microsoft Office including Word, Excel, PowerPoint experience is a plus.
Excellent communication skills, both oral and written to clearly and concisely communicate with internal and external team members.
Ability to work independently and collaboratively across cross-functional teams in a dynamic environment.
Preferred Skills:
Strategic thinking and project management skills.
Direct experience with handling and/or participating in regulatory body inspections.
A continuous improvement mindset and willingness to take initiative in solving problems.
Experience in both virtual sponsor and scaling global organization models.
#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.
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 [email protected].
Base Pay Salary Range
$120,000—$150,000 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.
Revolution Medicine enables physicians to integrate personalized medicine into their practices in order to more effectively treat patients.
Our genes play an important role in determining how we respond to about 75% of prescription drugs. Scientific research has demonstrated which genes predict these responses. According to the American Medical Association (AMA), 98% of physicians agree that knowing a patient’s genetic profile would help in prescribing medications. Yet, 90% of physicians do not feel they are adequately informed about how to apply genetic testing to treatment decisions.
Our mission is to improve the quality of patient care by helping doctors determine optimal treatment strategies and more accurately predict treatment responses. Revolution Medicine has developed ScriptMatch, an analytical process that enables physicians to easily incorporate genetic testing into their practices.
Our company solves a major issue in the clinical market and addresses an emerging trend in patient-driven healthcare: having clinical results that become part of the medical record and applicable to future treatments.
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