Senior Manager, Quality Engineering

Crinetics Pharmaceuticals • Headquarters, KY

4d • $133,000 - $166,000 • Hybrid

About The Position

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.

Requirements

• 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

Nice To Haves

• Advanced degree in a scientific or engineering discipline
• Experience with small molecule and/or solid oral dose manufacturing
• Experience with electronic QMS systems (e.g., Veeva Vault)
• Lean/Six Sigma or formal problem-solving training
• Experience supporting regulatory inspections or audits

Responsibilities

• 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.
• 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.

Benefits

• discretionary annual target bonus
• stock options
• ESPP
• 401k match
• top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance
• 20 days of PTO
• 10 paid holidays
• a winter company shutdown

What This Job Offers

• Job Type: Full-time
• Career Level: Senior