Manager, Quality Systems and Risk Management

📋 Description

• Own and drive formal risk management activities across the organization using ICH Q9 and FMEA.
• Maintain and improve the QMS; onboard Veeva Vault QMS modules and update procedures.
• Manage APQR reports; lead cross-functional data collection for timely completion.
• Generate quality metrics and KPIs for QMRs; analyze trends and report findings.
• Lead Lean Six Sigma initiatives; CAPA follow-through and process improvement.
• Participate in audits and regulatory inspections; ensure GxP compliance.

🎯 Requirements

• Bachelor’s degree in pharmacy, science, mathematics, or engineering.
• 8+ years in biotech/pharma FDA-regulated QA or related field.
• Strong risk management experience in GxP with ICH Q9 and FMEA.
• Lean Six Sigma knowledge or equivalent preferred.
• Proficiency with eQMS (Veeva Vault) and MS Office; SOP documentation.
• Experience with commercial marketed products.

🎁 Benefits

• Market-leading compensation.
• 401(k) with employer match.
• 100% employer-paid medical, dental, and vision premiums.
• Flexible PTO and company holidays.
• Hybrid work model with SF office visits.
• Employee Stock Purchase Program (ESPP).