Senior Manager, Quality Engineering

Crinetics Pharmaceuticals

Senior Manager, Quality Engineering at Crinetics Pharmaceuticals managing GMP Quality Risk Management program and cross-functional collaboration. Leading quality assurance efforts for product lifecycle and operational excellence.

Posted 6/6/2026full-timeRemote • California • 🇺🇸 United StatesSenior💰 $133,000 - $166,000 per yearWebsite

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Risk ManagementFMEArisk rankingGMP regulationsQuality Assuranceprocess validationtechnology transfermanufacturing operationsrisk assessment methodologiesQMS tools

Soft Skills

communicationorganizational skillsinfluencing skillscross-functional collaborationproblem-solvingdecision makingprioritizationleadershipfacilitationadaptability

Tools & Technologies

risk registersdashboardsmetricsCAPAchange controldeviationsQRM outputsproject management toolsdata analysis toolsquality systems

Industry Keywords

pharmaceuticalbiotechGMP environmentsICH Q9FDAEMAcommercial operationsproduct development lifecycleprocess verificationquality systems

About the role

Key responsibilities & impact

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 lifecycle, Technology transfer, Process validation and continued process verification, Manufacturing and supply chain activities.
Ensure 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.

Requirements

What you’ll need

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 environments
Demonstrated experience in Quality Risk Management methodologies (e.g., ICH Q9, FMEA, risk ranking)
Strong knowledge of GMP regulations and global expectations (e.g., FDA, EMA)
Experience supporting manufacturing, tech transfer, validation, and/or commercial operations
Proven ability to facilitate cross-functional risk assessments and drive outcomes
Strong communication, organizational, and influencing skills
Ability to manage multiple priorities in a fast-paced environment

Benefits

Comp & perks

Health insurance plans for employees (and their families)
Discretionary annual target bonus
Stock options
ESPP
401k match
20 days of PTO
10 paid holidays
Winter company shutdown