Remote Quality Systems & Risk Manager (QMS, ICH Q9, APQR)

Regulatory Jobs; United States; Híbrido; USD 126.000 - 153.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

401(k) with employer match

Employee Stock Purchase Program (ESPP)

Hybrid work model

Health premiums (employee and depend 0

Health Savings Account (HSA)

Fertility & family-forming benefits

Office visits to SF location

Descripción de la vacante

BridgeBio is seeking a Quality Systems and Risk Management Manager to lead formal risk assessments, maintain the QMS, and support APQR/QMR activities in a commercial-stage biopharmaceutical environment.

The ideal candidate has a bachelor’s degree in a relevant field, 8+ years in a regulated industry, and strong knowledge of Lean Six Sigma, FDA/ICH guidelines, and eQMS tools (preferably Veeva). Remote/hybrid with SF visits offered.

Formación

• Bachelor’s degree in pharmacy, science, mathematics or engineering.
• 8+ years in Biotech/Pharma QA or related FDA-regulated role.
• Experience leading formal risk management in a GxP environment.
• Knowledge of Lean Six Sigma methodologies preferred.
• Strong analytical, problem-solving and project management skills.
• Familiarity with FDA, ICH, EU GMP and GDP guidelines.
• Proficiency in eQMS, preferably Veeva, and MS Office.

Responsabilidades

• Lead formal risk management activities across the organization using ICH Q9 and FMEA.
• Maintain and improve the Quality Management System (QMS).
• Prepare and compile APQR reports with cross-functional data collection.
• Generate quality metrics for QMRs and present findings to stakeholders.
• Support Lean Six Sigma projects to reduce cycle times and improve quality.
• Participate in audits and regulatory inspections; ensure GxP compliance.
• Set work priorities to meet targets and assist SOP development and revision.

Conocimientos

Risk management

Lean Six Sigma

GxP compliance

eQMS (Veeva)

Data analysis

Educación

Bachelor’s degree in pharmacy/science/engineering

Herramientas

Veeva Vault QMS

Microsoft Office

Excel

Google Docs

Descripción del empleo

BridgeBio is seeking a Quality Systems and Risk Management Manager to lead formal risk assessments, maintain the QMS, and support APQR/QMR activities in a commercial-stage biopharmaceutical environment.

The ideal candidate has a bachelor’s degree in a relevant field, 8+ years in a regulated industry, and strong knowledge of Lean Six Sigma, FDA/ICH guidelines, and eQMS tools (preferably Veeva). Remote/hybrid with SF visits offered.