Director, Quality Systems

Position:
Director, Quality Systems Responsibilities

• Provide governance and oversight of the Quality Management System (QMS) to ensure sustained compliance with applicable GxP regulations.
• Monitor evolving global regulatory requirements and proactively update quality systems and procedures to maintain continuous compliance.
• Lead lifecycle management, configuration, and continuous improvement of electronic quality systems (EDMS, LMS, and related GxP platforms).
• Serve as system owner for Veeva Vault Quality (user management, system configuration, document workflows, reporting).
• Lead and support validation activities for GxP computerized systems (Computer System Validation (CSV) and Computer Software Assurance (CSA)).
• Ensure all GxP systems remain validated throughout their lifecycle (change management and periodic review).
• Ensure compliance with 21 CFR Part 11 and applicable electronic records/signature requirements.
• Own and continuously improve document control (authoring, review, approval, distribution, archiving).
• Lead administration and optimization of the learning management system (curricula, role-based training, compliance tracking).
• Develop, monitor, analyze, and report quality system metrics; support management review.
• Conduct internal audits and ensure timely investigation/resolution of gaps or nonconformances.
• Identify and drive continuous improvement initiatives to enhance efficiency, scalability, and compliance.
• Support inspections and audits (regulatory authority and partner audits).
• Contribute to supplier quality, quality risk management, and broader QMS initiatives as needed.
• Perform additional duties as assigned.

• Bachelor’s degree in a related scientific or technical discipline.
• 10+ years’ industry experience supporting GxP quality systems (biologics, pharmaceuticals, medical devices, or combination products).
• Strong electronic document management system knowledge;
  Veeva Vault Quality experience preferred.
• Expertise in CSV, CSA, and GxP computerized system lifecycle management.
• In-depth knowledge of FDA, ICH, and global GxP regulations, including 21 CFR Part 11.
• Strong problem-solving, organizational, and communication skills.
• Ability to work independently and collaborate cross-functionally in a fast-paced environment.
• High attention to detail and adaptability; continuous improvement mindset.

Brisbane, California; preference for San Francisco Bay Area.

• Flexible work schedules, remote opportunities, shuttle service, competitive base salary/equity, employee stock purchase plan, and comprehensive health benefits including 401(k) and flexible spending plans.