Senior Manager, Quality Systems Product Complaints & Shipment Excursions

Redwood City, CA - USA

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The companys 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 Revolutionariesin a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity:

Provide day-to-day oversight and management of clinical and commercial Product Complaints and Temperature/Shipment Excursions ensuring consistent compliant execution and continuous monitoring including improvement of these processes within the Quality Management System (QMS).
Own the end-to-end lifecycle for complaints and excursions including intake triage investigation escalation impact assessment documentation and timely closure in accordance with regulatory and internal requirements.
Lead and perform assessments and investigations coordinating cross-functional support from internal teams and external partners to ensure timely thorough and compliant resolution.
Partner with Pharmacovigilance/Safety Regulatory Affairs Manufacturing Quality Control and Supply Chain to ensure appropriate escalation investigation and regulatory alignment.
Ensure risk-based evaluation and linkage of complaints and excursions to deviations CAPAs change controls and regulatory reporting (e.g. Field Alerts) as applicable.
Design maintain and continuously improve the Product Complaints and Shipment Excursions processes including SOPs work instructions workflows templates training materials and system configurations.
Drive metrics trending and signal detection to identify emerging quality risks patient impact and systemic issues and recommend corrective and preventive actions.
Provide hands-on SME support training and guidance to internal teams and external partners to promote consistent and compliant handling practices.
Support management review and quality governance forums by presenting summaries trends and risk assessments.
Act as SME for internal audits external audits and regulatory inspections ensuring inspection readiness across the product lifecycle.

Required Skills Experience and Education:

Bachelors degree in Science Engineering Computer Systems or related field (advanced degree preferred).
Minimum 8-10 years of experience in Quality Systems within the pharmaceutical or biotechnology industry.
Demonstrate expertise in Product Complaints management and Shipment Excursions and electronic QMS tools (preferably Veeva Quality Vault).
Experience with GMP manufacturing investigations working cross-functionally with internal stakeholders and external partners.
Excellent analytical investigation and problem-solving capabilities.
Strong understanding of GxP regulations FDA and EMA expectations for product complaints and ICH Q10 principles.
Experience supporting late-stage development and/or commercial products in an outsourced manufacturing and testing model.

Preferred Skills:

Strong organizational project management and prioritization skills.
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 ourCCPA additional information please contact .

Base Pay Salary Range

$164000$205000 USD

Required Experience:

Senior Manager