Director, Quality Engineering
Crinetics Pharmaceuticals
4 months ago
Remote friendly (United States)
United States
$190,000 - $223,000 USD yearly
Operations
Responsibilities:
- Lead development and execution of global GMP quality engineering strategies.
- Serve as organizational lead for Quality Risk Management (QRM) using risk-based approaches.
- Drive continuous improvement (Lean, Six Sigma, root cause analysis).
- Enhance and maintain core quality systems (CAPA, deviation management, change control, batch release, investigations) and ensure inspection readiness.
- Strengthen data integrity controls aligned to ALCOA+.
- Provide end-to-end quality oversight across manufacturing, tech transfer, scale-up, validation, and commercial production.
- Direct regulatory inspections and internal audits; ensure timely, sustainable remediation of observations.
- Collaborate cross-functionally (Manufacturing, QC, Regulatory Affairs, Supply Chain, Commercial).
- Implement risk-based monitoring/metrics; guide quality input for NPI/launches and supply chain strategies.
- Lead/mentor a global quality team; represent Quality in governance forums.
Required:
- Bachelor’s in a science discipline; 12+ years QA/pharma-biotech experience, including 8+ years supervisory/leadership.
- Deep GMP-compliant manufacturing expertise; understanding of FDA/EMA/MHRA/PMDA requirements.
- Experience leading quality transformation initiatives.
- Strong background in Drug Substance and/or Drug Product Manufacturing (small molecules/solid oral dose a plus).
- Excellent communication (verbal/written, SOP writing), organizational skills, attention to detail.
Preferred:
- Solid dosage or small molecule experience; other dosage forms acceptable.
- Veeva QMS (Quality Vault).
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.
- Lead development and execution of global GMP quality engineering strategies.
- Serve as organizational lead for Quality Risk Management (QRM) using risk-based approaches.
- Drive continuous improvement (Lean, Six Sigma, root cause analysis).
- Enhance and maintain core quality systems (CAPA, deviation management, change control, batch release, investigations) and ensure inspection readiness.
- Strengthen data integrity controls aligned to ALCOA+.
- Provide end-to-end quality oversight across manufacturing, tech transfer, scale-up, validation, and commercial production.
- Direct regulatory inspections and internal audits; ensure timely, sustainable remediation of observations.
- Collaborate cross-functionally (Manufacturing, QC, Regulatory Affairs, Supply Chain, Commercial).
- Implement risk-based monitoring/metrics; guide quality input for NPI/launches and supply chain strategies.
- Lead/mentor a global quality team; represent Quality in governance forums.
Required:
- Bachelor’s in a science discipline; 12+ years QA/pharma-biotech experience, including 8+ years supervisory/leadership.
- Deep GMP-compliant manufacturing expertise; understanding of FDA/EMA/MHRA/PMDA requirements.
- Experience leading quality transformation initiatives.
- Strong background in Drug Substance and/or Drug Product Manufacturing (small molecules/solid oral dose a plus).
- Excellent communication (verbal/written, SOP writing), organizational skills, attention to detail.
Preferred:
- Solid dosage or small molecule experience; other dosage forms acceptable.
- Veeva QMS (Quality Vault).
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.