Director, Quality Systems (Hybrid)

About the Role

The Director, Quality Systems provides strategic leadership and hands-on oversight for the design, implementation, maintenance, and continuous improvement of the Quality Management System (QMS). This role serves as a subject matter expert for GxP quality systems and is accountable for system governance, compliance, and operational excellence across electronic quality platforms. The Director partners cross-functionally to ensure inspection-ready quality systems that meet global regulatory requirements, support clinical-stage development, and scale with organizational growth.

Responsibilities

• Provide governance and oversight of the Quality Management System, ensuring sustained compliance with applicable GxP regulations.
• Monitor emerging and evolving global regulatory requirements and proactively drive updates to quality systems and procedures to maintain a continuous state of compliance.
• Lead the lifecycle management, configuration, and continuous improvement of electronic quality systems, including EDMS, LMS, and related GxP platforms.
• Serve as system owner for Veeva Vault Quality, including user management, system configuration, document workflows, and reporting.
• Lead and support validation activities for GxP computerized systems, demonstrating expertise in Computer System Validation (CSV) and Computer Software Assurance (CSA).
• Ensure all GxP systems remain in a validated state throughout their lifecycle, including change management and periodic review.
• Ensure compliance with 21 CFR Part 11 and applicable electronic records and signature requirements.
• Own and continuously improve the document control process, ensuring controlled documents are authored, reviewed, approved, distributed, and archived in compliance with internal procedures and regulatory expectations.
• Lead the administration and optimization of the learning management system, including training curricula, role-based training assignments, and compliance tracking.
• Partner with functional leaders to ensure timely document review, approval, and training completion across the organization.
• Develop, monitor, analyze, and report quality system metrics to assess system health and support management review.
• Conduct periodic internal audits of quality systems and document control processes; ensure timely investigation and resolution of identified gaps or nonconformances.
• Identify and drive continuous improvement initiatives to enhance efficiency, scalability, and compliance of quality systems.
• Support inspections and audits, including regulatory authority and partner audits.
• Contribute to supplier quality, quality risk management, and broader QMS initiatives as needed.
• Perform additional duties as assigned by management.

Requirements

• Bachelor’s degree in a related scientific or technical discipline required.
• Minimum of ten (10) years of industry experience supporting GxP quality systems within biologics, pharmaceuticals, medical devices, or combination products.
• Strong working knowledge of electronic document management systems; Veeva Vault Quality experience highly preferred.
• Demonstrated expertise in CSV, CSA, and GxP computerized system lifecycle management.
• In-depth understanding of FDA, ICH, and global GxP regulations, including 21 CFR Part 11.
• Strong problem-solving, organizational, and communication skills.
• Ability to work independently while effectively collaborating in a cross-functional, fast-paced environment.
• High attention to detail with the agility to adapt to changing priorities.
• Continuous improvement mindset and comfort operating in a growing clinical-stage organization.

Pay

$212,000–$228,000 based on experience.