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Director, GMP Quality

Revolution Medicines

Redwood City, CA, US
  • Job Type: Full-Time
  • Function: Engineering QA
  • Industry: Biotechnology
  • Post Date: 02/12/2024
  • Website: www.revmed.com
  • Company Address: 700 Saginaw Dr, Redwood City, California 94063, US

About Revolution Medicines

REVOLUTION Medicines discovers and develops new drugs that harness the therapeutic potential of frontier oncology targets on behalf of cancer patients.

Job 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.

 

The Opportunity:

Revolution Medicines is seeking a motivated individual with an accomplished GMP Quality background to play a critical role as a GMP Quality leader within the Regulatory & Quality Organization. This position will be responsible for ensuring adherence to applicable industry regulations and standards related to GMP manufacturing and associated activities. This is a leadership role with responsibilities for operational support for assigned programs, reporting into the Senior Director, GXP Quality.

 

Responsibilities:

  • Provide leadership in a fast-paced environment with high quality and regulatory standards for late-stage small molecule manufacturing activities.

  • Ensure the Validation Master Plan, Validation Policy, and applicable SOPs, WIs, templates, and lists reflect current practice, industry guidelines, and regulatory requirements, for small molecule manufacturing.

  • Work collaboratively with various departments to ensure that all required prerequisites are appropriately developed to support validation activities.

  • Provide validation guidance as needed to assess impact to the validated status and/or product quality, and identify appropriate actions based on risk.

  • Review and approve validation protocols and reports; assist in development and execution as needed.

  • Coordinate with external vendors, contractors and consultants as required to ensure validation deliverables and schedules are met.

  • Oversee the contract manufacturing organizations and represent QA as the person-in-the-plant (PIP) during manufacturing campaigns, as needed.

  • Participate in audits as the QA Validation representative.

  • Represent QA on cross-functional operational teams (i.e., CMC) and serve as a resource for quality and compliance questions, issues, and planning across the development organization, including providing guidance and sound decisions based on data, current global regulations, industry standards, and best practices.

  • Perform review of batch records and test data and perform product dispositions.

  • Develop and track metrics, analyze compliance issues and trends, and make recommendations to improve quality systems and overall compliance in operational activities.

  • Represent QA on other cross-functional meetings, including Quality Review Board meetings.

  • Collaborate with internal and external stakeholders on deviation investigations, CAPA plans, change controls, shelf-life extensions, and revisions to documentation.

  • Lead, mentor, and support junior members of the Quality team.

Required Experience, Skills, and Education:

  • A Bachelor's degree in a scientific or technical discipline is required.

  • A minimum of 12 years of experience in GMP Quality in the pharmaceutical industry is required with focus on small molecule manufacturing, with 5 years managerial experience in GMP area.

  • Experience in Inspection Readiness with domestic (FDA) and ex-US agencies.

  • Highly responsible, high integrity, and self-motivated professional with enthusiasm and passion for the work.

  • Must possess proficient knowledge and understanding of regulatory guidelines and industry best practice for validation requirements for small molecule manufacturing.

  • Analyze data, utilizing statistical methods, generated by validation studies to determine process capabilities.

  • Strong technical knowledge of small molecule process development, analytical chemistry, and pharmaceutical manufacturing technologies and processes.

  • Ability to lead with adherence to RevMed Core Values and work independently with minimal supervision to critically evaluate and troubleshoot complex problems with diligence.

  • Effective organization, CMO management, and project management skills.

  • Excellent oral and written communication skills demonstrated through interactions internally and externally, at all levels.

  • Computer literacy in Microsoft Office programs, including Outlook, Word, Access, and Excel.

Revolution Medicines currently requires that all personnel and visitors to its offices be fully vaccinated against COVID-19. This role will require that the employee meet with company employees and work from the company’s offices. Given that these essential functions of the role must be performed on-site, this position requires full COVID-19 vaccination, subject to applicable law.

The expected salary range for this role is $195,000 to $245,000.  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 privacy@revmed.com.

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