Hiring: Manager, Quality Systems and Risk Management Company: BridgeBio Location: United States Job Posted Time: 2026-09-12 11:47:39 Employment Type: Full-time / Remote Target Skills & Keywords : Microsoft Excel, Microsoft Office, Project Management, Regulatory Compliance, Risk Management, Root Cause Analysis, Six Sigma, Vault About the job Experience: •8 years of experience working in a Biotech or Pharmaceutical FDA regulated industry in QA or a related field or an equivalent combination of education, training, and/or experience from which comparable knowledge, skills, and abilities have been attained Required Skills: •The ideal candidate is detail-oriented, highly organized, and eager to develop deep expertise across quality systems in a commercial-stage biopharmaceutical environment and bring a collaborative mindset and the ability to work effectively across functions to support quality deliverables and timelines. •Own and drive formal risk management activities across the organization by leading risk assessments, maintaining risk registers, and applying risk frameworks such as ICH Q9 and FMEA. Integrate risk-based thinking into day-to-day QMS activities and serve as the subject matter expert for risk management methodology. •Assist in the generation of Quality metrics and Key Performance Indicators (KPIs) for Quality Management Reviews (QMRs) etc. Analyze and present quality data to identify trends, risks, and opportunities for improvement. Collaborate with internal and external key stakeholders for compilation of quality metrics, APQR, etc. •Assist in executing process improvement initiatives using Lean Six Sigma principles, including data gathering, root cause analysis support, and CAPA follow-through. Contribute to improvement projects aimed at reducing cycle times and enhancing quality system efficiency, and apply Lean Six Sigma tools as part of ongoing quality work. •Participate in audits and regulatory inspections. •Ensure all activities comply with current GxP regulatory standards and internal procedures. •Establish work priorities to meet targets and timelines and effectively manage competing priorities with minimal escalations. •Assist in preparation, review and revision of Standard Operating Procedures (SOPs), as required. Qualifications: •Bachelor’s degree or equivalent in pharmacy, science, mathematics or engineering required •A minimum of 8 years of experience working in a Biotech or Pharmaceutical FDA regulated industry in QA or a related field or an equivalent combination of education, training, and/or experience from which comparable knowledge, skills, and abilities have been attained •Strong experience and knowledge leading formal risk management activities in a GxP environment, including risk identification, assessment, and mitigation using tools such as FMEA, risk ranking, and ICH Q9 frameworks •Knowledge of Lean Six Sigma Methodologies or equivalent is preferred •Excellent analytical, problem-solving, and project management skills with keen attention to detail •Knowledge of regulatory requirements and guidelines (e.g., FDA, ICH, EU GMP, GDP) •Proficiency in eQMS preferably with prior Veeva experience, Microsoft Office, Excel, Google Docs, etc. Compensation: •$126,400 - $152,700 / year •Flexible work environment (work from home / hybrid options) •Competitive benefits and rewards package Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!