About the job
Revolution Medicines develops targeted therapies for patients with RAS-addicted cancers. The company’s pipeline includes RAS(ON) inhibitors such as daraxonrasib (RMC-6236), elironrasib (RMC-6291), zoldonrasib (RMC-9805), and RMC-5127, each focused on specific oncogenic variants of RAS proteins. The team is dedicated to advancing treatments for those affected by mutations in the RAS signaling pathway.
The Manager of Document Management in Analytical Development & Quality Control is based in Redwood City, California. This role oversees the entire lifecycle of controlled documents within Analytical Development and Quality Control (ADQC), supporting both regulatory compliance and internal quality standards. The position manages documentation for internal teams as well as external partners.
Key Responsibilities
- Oversee creation, review, approval, issuance, and archiving of controlled documents, including SOPs and work instructions.
- Develop and maintain document management practices and change control processes to meet regulatory and industry standards.
- Collaborate with cross-functional teams to assess, prioritize, and manage change requests.
- Track, document, and close change controls, including conducting impact assessments and obtaining required approvals.
- Communicate changes and their implications to stakeholders, such as senior management and regulatory affairs.
- Lead meetings across departments to keep documentation accurate and current.
- Monitor document metrics, identify trends, and highlight areas for improvement.
- Continuously evaluate and refine document management processes to enhance efficiency and effectiveness.
Requirements
- Strong experience in the pharmaceutical or biotech sector.
- Background in document management, quality control, and regulatory compliance.
