Manager, Document Management, Analytical Development & Quality Control at Revolution Medicines

**Who this is for** This role is for a detail-oriented professional with a strong background in document management and quality systems, looking to support anal

Work type: hybrid

Location: Redwood City, California, United States

Salary: $143,000 – $178,000/yr

Type: Full-time

Summary

**Who this is for** This role is for a detail-oriented professional with a strong background in document management and quality systems, looking to support analytical development and quality control teams. **Key highlights** You will own the lifecycle of controlled documentation, manage change control processes, and drive continuous improvement initiatives to ensure full regulatory compliance for clinical-stage products. **You might be a good fit if you...** - Have 6+ years of experience in document control or quality documentation within the pharmaceutical or biotech industry. - Are highly skilled in managing change controls and maintaining document metrics. - Can effectively lead cross-functional meetings and translate complex compliance requirements for various stakeholders. - Possess excellent organizational skills and a proactive approach to process improvement.

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:

As a manager of document management, you will be responsible for overseeing the lifecycle of controlled documents. This role ensures compliance with regulatory requirements, company quality standards, and effective document control practices across internal and external stakeholders. We are looking for a detail-oriented and proactive individual with a strong background in pharmaceutical or biotech industries. This position develops strategic plans related to change control, other ADQC documents, and the implementation of robust corrective actions to support Analytical Development and Quality Control by applying function expertise.

• Manage the creation, review, approval, issuance, and archival of controlled documents, including SOPs, work instructions, and documents initiated at contract organizations.

• Develop and implement effective document management including change control processes and procedures to ensure compliance with regulatory requirements and industry best practices.

• Collaborate with cross-functional teams to evaluate, prioritize, and manage change requests.

• Ensure proper tracking, documentation, and closure of change controls, including impact assessment, change action executions, and required approvals.

• Communicate changes and their impact to relevant stakeholders, including senior management, quality assurance, regulatory affairs and contract organizations.

• Coordinate and/or lead cross-functional meetings with multiple departments to maintain accurate and up-to-date documentation.

• Monitor and track document metrics to identify trends, gaps, and areas for improvement.

• Continuously evaluate and improve document management to increase efficiency and effectiveness.

• Act as a subject matter expert for document management related matters and provide guidance and support to colleagues across the organization.

• Manage multiple assignments and changing priorities through robust organizational, planning, and project management skills.

• Foster a culture of quality and compliance within the organization through proactive communication and collaboration with all departments.

• BS in Life Science, Chemistry, Pharmaceutical Science or related discipline.

• 6+ years in document control or relevant experience within pharmaceutical or biotech industry.

• Strong problem-solving skills with sound technically driven decision-making ability.

• Excellent communication skills (verbal, written and technical), strong interpersonal/collaboration skills and planning skills.

• Ability to think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems.

• Ability to multi-task and thrive in a fast-paced innovative environment.

• Have a strong attention to detail.

• Stay current with industry regulations and guidelines related to controlled documents and make recommendations for process improvements as needed.

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.

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