[Hiring] Senior Manager, Quality Engineering @Crinetics Pharmaceuticals

Role Description

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
• Quality operations

This position emphasizes hands-on facilitation, cross-functional engagement, and lifecycle oversight of risk, with accountability for program execution and performance.

Essential Job Functions and 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.
• 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.
• Collaborate with Quality, Manufacturing, Quality Control, Regulatory Affairs, and Supply Chain to ensure risk-informed decision making.
• 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).
• Identify opportunities for continuous improvement in risk management and/or Quality processes.
• Contribute to the development and refinement of risk-based procedures, templates, and training materials.
• Support regulatory inspection readiness activities.
• Provide QRM support during audits and inspections.
• Ensure alignment with global regulatory expectations (e.g., FDA, EMA).
• Ensure that risk-related data is accurate, complete, and maintained in accordance with ALCOA+ principles.
• Develop and monitor risk-based performance metrics and KPIs.
• 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.

Qualifications

• 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.

Requirements

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

Benefits

• Salary range: $133,000 - $166,000.
• Discretionary annual target bonus.
• Stock options.
• Employee Stock Purchase Plan (ESPP).
• 401k match.
• Top-notch health insurance plans for employees (and their families) including medical, dental, vision, and basic life insurance.
• 20 days of PTO.
• 10 paid holidays.
• Winter company shutdown.