Senior Manager, Quality Engineering
Crinetics Pharmaceuticals
June 27, 2026
Remote friendly (United States)
United States
Operations
Position: Senior Manager, Quality Engineering (GMP)
Responsibilities:
- Lead 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 identify, categorize, and quantify risk.
- Embed risk-based decisions across product development lifecycle, technology transfer, process validation/continued process verification, and manufacturing/supply chain activities.
- Ensure risks are documented, trended, escalated, and maintained in QMS tools; maintain risk registers, dashboards, and metrics.
- Drive alignment between QRM outputs and quality systems (deviations, CAPA, change control) and provide QRM representation/support on project teams.
- Provide risk-based Quality input to process changes, investigations, and technical decisions.
- Support inspection readiness with inspection-ready, traceable, defensible risk practices; ensure alignment with FDA/EMA expectations.
- Develop/monitor risk-based performance metrics; mentor others; act as QRM subject matter expert.
Required:
- Bachelor’s degree in a scientific discipline.
- 12+ years Quality Assurance experience in pharmaceutical/biotech GMP.
- Hands-on facilitation of QRM methods (ICH Q9, FMEA, risk ranking) in GMP.
- Strong knowledge of GMP regulations; experience supporting manufacturing, tech transfer, validation, and/or commercial operations.
- Proven cross-functional facilitation and strong communication/organizational/influencing skills; manage multiple priorities; influence matrixed teams.
Preferred:
- Advanced degree.
- Small molecule/solid oral dose manufacturing experience.
- Electronic QMS (e.g., Veeva Vault).
- Lean/Six Sigma or problem-solving training; audit/inspection support.
Benefits (as stated):
- Discretionary annual target bonus, stock options, ESPP, 401k match; medical/dental/vision/basic life; 20 days PTO, 10 paid holidays, winter company shutdown.
Salary Range: $133,000–$166,000.
Responsibilities:
- Lead 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 identify, categorize, and quantify risk.
- Embed risk-based decisions across product development lifecycle, technology transfer, process validation/continued process verification, and manufacturing/supply chain activities.
- Ensure risks are documented, trended, escalated, and maintained in QMS tools; maintain risk registers, dashboards, and metrics.
- Drive alignment between QRM outputs and quality systems (deviations, CAPA, change control) and provide QRM representation/support on project teams.
- Provide risk-based Quality input to process changes, investigations, and technical decisions.
- Support inspection readiness with inspection-ready, traceable, defensible risk practices; ensure alignment with FDA/EMA expectations.
- Develop/monitor risk-based performance metrics; mentor others; act as QRM subject matter expert.
Required:
- Bachelor’s degree in a scientific discipline.
- 12+ years Quality Assurance experience in pharmaceutical/biotech GMP.
- Hands-on facilitation of QRM methods (ICH Q9, FMEA, risk ranking) in GMP.
- Strong knowledge of GMP regulations; experience supporting manufacturing, tech transfer, validation, and/or commercial operations.
- Proven cross-functional facilitation and strong communication/organizational/influencing skills; manage multiple priorities; influence matrixed teams.
Preferred:
- Advanced degree.
- Small molecule/solid oral dose manufacturing experience.
- Electronic QMS (e.g., Veeva Vault).
- Lean/Six Sigma or problem-solving training; audit/inspection support.
Benefits (as stated):
- Discretionary annual target bonus, stock options, ESPP, 401k match; medical/dental/vision/basic life; 20 days PTO, 10 paid holidays, winter company shutdown.
Salary Range: $133,000–$166,000.