Manager, Quality Systems and Risk Management

Responsibilities

• Own and drive formal risk management activities, including leading risk assessments and maintaining risk registers using ICH Q9 and FMEA frameworks.
• Support the maintenance and continuous improvement of the Quality Management System (QMS), including the implementation of new Veeva Vault modules.
• Manage the preparation and compilation of Annual Product Quality Review (APQR) reports and escalate potential quality or regulatory trends.
• Generate Quality metrics and Key Performance Indicators (KPIs) for Quality Management Reviews (QMRs).
• Execute process improvement initiatives using Lean Six Sigma principles, including root cause analysis and CAPA follow-through.
• Participate in audits and regulatory inspections to ensure compliance with GxP standards.
• Prepare, review, and revise Standard Operating Procedures (SOPs).

Requirements

• Bachelor's degree in pharmacy, science, mathematics, or engineering.
• Minimum of 8 years of experience in Biotech or Pharmaceutical QA within an FDA-regulated industry.
• Strong experience leading formal risk management activities (FMEA, risk ranking, ICH Q9).
• Deep knowledge of regulatory requirements including FDA, ICH, EU GMP, and GDP.
• Proficiency in eQMS (preferably Veeva Vault) and Microsoft Office/Google Docs.
• Experience working with commercial marketed products.

Preferred Qualifications

• Knowledge of Lean Six Sigma methodologies or equivalent.

Benefits

• Market-leading compensation and 401(k) with employer match.
• 100% employer-paid medical, dental, and vision premiums for employees and dependents.
• Flexible, “take-what-you-need” paid time off and comprehensive parental leave.
• Employee Stock Purchase Program (ESPP).
• Fertility and family-forming benefits.
• Hybrid work model with professional development opportunities.

About the Company

BridgeBio is a biopharmaceutical company that uses a unique "moneyball for biotech" approach to accelerate the development of life-changing medicines for patients with rare diseases. We value curiosity, experimentation, and the empowerment of experts to solve complex problems and reengineer the future of biopharma.