Quality Assurance Manager- Hybrid

About the Role

The Quality Assurance Manager provides day-to-day leadership for key Quality Management System (QMS) processes and the Quality team, ensuring continued suitability, compliance, and scalability of the QMS as the business grows. This role is accountable for oversight and effectiveness of change control, Computer System Validation (CSV), including validation of GxP-relevant software, AI-assisted/low-code/no-code tools, and native-built applications, risk management, supplier/vendor quality, deviation/complaint handling, CAPA, internal auditing, and training. The QA Manager partners cross-functionally to drive a culture of quality, proactive risk management, and continuous improvement.

Primary Responsibilities

• Lead and develop QA staff through coaching, workload prioritization, performance feedback, and training plans.
• Own assigned QMS processes end-to-end, ensuring procedures are current, effective, and aligned to applicable FDA/ISO expectations.
• Promote organizational awareness of the Quality System; deliver and/or coordinate quality training, tools, and best practices.
• Establish quality objectives and key performance indicators (KPIs); compile, trend, and report quality metrics and corrective actions.
• Facilitate or contribute to management review inputs (e.g., KPI trends, audit outcomes, CAPA effectiveness, and risk status).

Position Requirements

• Bachelor's Degree in Biology, Chemistry, Life Sciences, Engineering, or related field (required).
• 8+ years of experience in quality supporting clinical research and/or pharmaceutical/biotech development; advanced degree may substitute for a portion of experience.
• 3+ years of experience leading others (people leadership, team lead, or mentorship/accountability for work output).
• Demonstrated expertise in QMS processes: change control, deviations/nonconformances, complaints, CAPA, risk management, supplier quality, audits, and training.
• Demonstrated experience with Computer System Validation (CSV) in a regulated environment, including risk-based validation of software, spreadsheets, SaaS platforms, and workflow tools.
• Experience validating AI-assisted, low-code/no-code, and native-built applications, with the ability to assess intended use, system risk, testing rigor, data integrity, and change control requirements.
• Experience compiling and trending quality metrics and driving data-based continuous improvement.
• Strong working knowledge of FDA and ISO concepts relevant to the organization; ability to interpret requirements and translate them into practical processes.
• Working knowledge of 21 CFR Part 11, electronic records/electronic signatures expectations, and risk-based validation approaches for digital systems.
• Regulatory/quality certifications (ASQ/SQA) and/or Lean/Six Sigma (Green Belt/Black Belt) preferred; active continuing education a plus.
• Strong computer literacy, excellent written and verbal communication skills, and strong organizational/time management skills.
• Comfortable operating with autonomy, influencing without authority, and making sound quality judgments under time constraints.

Salary

$110,000 to $115,000 annually plus an annual performance based bonus

QA & Compliance

Los Angeles, CA