Director, Quality Systems (Hybrid)

Position:

Director, Quality Systems provides strategic leadership and hands-on oversight for the design, implementation, maintenance, and continuous improvement of theQuality Management System (QMS). This role serves as a subject matter expert forGxPquality 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 include:

Quality Systems Leadership

• Provide governance and oversight of theQuality Management System, ensuring sustained compliance with applicableGxPregulations.
• Monitor emerging and evolving global regulatory requirements and proactively drive updates to quality systems and procedures tomaintaina continuous state of compliance.

Electronic Quality Systems

• Lead the lifecycle management, configuration, and continuous improvement of electronic quality systems, including EDMS, LMS, and relatedGxPplatforms.
• Serve as system owner for Veeva Vault Quality, including user management, system configuration, document workflows, and reporting.

Computer System Validation & Assurance

• Lead and support validation activities forGxPcomputerized systems,demonstratingexpertisein Computer System Validation (CSV) and Computer Software Assurance (CSA).
• Ensure allGxPsystemsremainin 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.

Document Control & Training

• 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 ensuretimelydocument review, approval, and training completion across the organization.

Metrics, Audits & Continuous Improvement

• 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; ensuretimelyinvestigation and resolution of identified gaps or nonconformances.
• Identifyand drive continuous improvement initiatives to enhance efficiency, scalability, and compliance of quality systems.

Additional Quality Support

• Support inspections and audits, including regulatory authority and partner audits.
• Contribute to supplier quality, quality risk management, and broader QMS initiatives as needed.
• Performadditionalduties as assigned by management.

Education, Experience, and Skills:

Required:

• Bachelor’s degree ina relatedscientific or technical disciplinerequired.
• Minimum of ten (10) years of industry experience supportingGxPquality systems withinbiologics, pharmaceuticals, medical devices, or combination products.
• Strong working knowledge of electronic document management systems;Veeva Vault Quality experience highly preferred .
• Demonstratedexpertisein CSV, CSA, andGxPcomputerized system lifecycle management.
• In-depth understanding of FDA, ICH, and globalGxPregulations, 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 comfortoperatingin a growing clinical-stage organization.

Comp $212-228K based on experience