Manager, Quality Systems and Risk Management

Role: Support and enhance the organization's risk management and Quality Management System (QMS) in a biopharmaceutical setting. Responsibilities: Lead formal risk assessments using frameworks like ICH Q9 and FMEA, maintain and improve QMS processes including Veeva Vault modules, compile and review Annual Product Quality Reports (APQR), generate quality metrics, and support process improvements with Lean Six Sigma tools. Additionally, participate in audits and regulatory inspections, ensuring compliance with GxP standards, and assist in SOP updates. Requirements: Bachelor's degree in pharmacy, science, mathematics, or engineering; minimum 8 years of experience in QA within FDA-regulated biopharma; expertise in risk management methodologies, GxP compliance, and regulatory guidelines (FDA, ICH, EU GMP); proficiency with eQMS (preferably Veeva), Microsoft Office, and data analysis. Preferred: Knowledge of Lean Six Sigma; experience with commercial products. HighValue: Focus on risk management and QMS within a commercial-stage biopharma, supporting manufacturing and quality assurance functions in a remote/hybrid work environment. Travel is not specified.