Senior Manager, Quality Engineering

Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. Crinetics is known for its inclusive workplace culture. We are also a dog-friendly workplace. This is an exciting time to join Crinetics as we shape our organization into the world’s premier fully-integrated endocrine company from discovery to patients. Join our team as we transform the lives of others.Position Summary:The Senior Manager, Quality Engineering (GMP) is responsible for the execution, administration, and continuous facilitation of the Quality Risk Management (QRM) program within GMP operations. This role partners closely with Technical Operations and cross-functional stakeholders to ensure risks are proactively identified, assessed, documented, and managed throughout the product lifecycle.Reporting to the Director, Quality Engineering, this role serves as a key operational leader and subject matter expert for QRM, supporting the deployment of scalable, risk-based approaches across manufacturing, technology transfer, validation, commercial production activities and quality operations. The Senior Manager will work within project teams and governance forums to ensure consistent application of risk management principles, while contributing to inspection readiness, continuous improvement, and overall quality system effectiveness.This position emphasizes hands-on facilitation, cross-functional engagement, and lifecycle oversight of risk, with accountability for program execution and performance, while the Director retains ownership of program strategy and evolution.Essential Job Functions and Responsibilities:These may include but are not limited to:Lead the administration and day-to-day execution of the GMP Quality Risk Management (QRM) program across GMP quality, development and commercial operations.Facilitate structured risk assessments (e.g., FMEA, risk ranking/filtering) with cross-functional SMEs to ensure consistent identification, categorization, and quantification of risk.Partner with Technical Operations project teams to embed risk-based decision making into:Product development lifecycleTechnology transferProcess validation and continued process verificationManufacturing and supply chain activitiesEnsure risks are appropriately documented, trended, escalated, and maintained through their full lifecycle within QMS tools.Establish and maintain risk registers, dashboards, and metrics to provide visibility into risk profiles and trends.Drive alignment between QRM outputs and core quality systems (e.g., deviations, CAPA, change control).Serve as the Quality Engineering representative on project teams or facilitate structured touchpoints with project leads to ensure integration of QRM principles.Collaborate with Quality, Manufacturing, Quality Control, Regulatory Affairs, and Supply Chain to ensure risk-informed decision making across GMP operations.Provide Quality input into process changes, investigations, and technical decisions with a risk-based perspective.Support the effectiveness of key quality systems (e.g., CAPA, deviation management, change control) by ensuring risk prioritization and linkage to QRM outputs.Identify opportunities for continuous improvement in risk management and/or Quality processes, tools, and integration with the QMS.Contribute to the development and refinement of risk-based procedures, templates, and training materials.Support regulatory inspection readiness activities by ensuring risk management practices are inspection-ready, traceable, and defensible.Provide QRM support during audits and inspections, including risk-based justifications and documentation of decision-making.Ensure alignment with global regulatory expectations (e.g., FDA, EMA) regarding risk-based quality systems.Ensure that risk-related data is accurate, complete, and maintained in accordance with ALCOA+ principles.Develop and monitor risk-based performance metrics and KPIs to identify emerging signals and drive proactive action.Provide mentorship and guidance to junior team members and cross-functional partners on QRM principles and tools.Act as a subject matter expert in QRM within GMP operations.Other duties as assigned.Education and Experience:Required:Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biology, Engineering or related field)Minimum of 12 years of experience in Quality Assurance within pharmaceutical/biotech GMP environmentsDemonstrated experience in Quality Risk Management methodologies (e.g., ICH Q9, FMEA, risk