revolutionmedicines
Senior QA Specialist, Quality Systems, GxP Training
At a Glance
- Location
- Redwood City, California, United States
- Work Regime
- hybrid
- Experience
- 5+ years
- Posted
- 2026-06-18T17:43:46-04:00
Key Requirements
Required Skills
Domain Knowledge
- Biotech
- Education
- Finance
- Medical
- Pharmaceutical
- Regulatory
Requirements
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 working with Veeva QualitySuite electronic platforms (QualityDocs, Training, QMS).
Direct experience with handling and/or participating in regulatory body inspections.
Experience in both virtual sponsor and scaling global organization models.
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.
Responsibilities
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.
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.
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).