Associate Director, Quality Systems

This is a fully remote position, open to applicants in California.

📋 Description

• Oversee the daily operations and administration of the electronic Quality Management System (QMS), which includes managing users, roles, permissions, workflows, document and record types, metadata, and system configuration.

• Administer document and records processes, encompassing lifecycle management, classification, retention, archival status, retrieval, and controls for GxP and company records.

• Collaborate with various functional groups to ensure the maintenance of company policies, procedures, and GxP documents within the document management system.

• Handle onboarding and offboarding processes related to QMS access, training assignments, and quality system requirements.

• Oversee the GxP training program, which includes role-based training matrices, curricula, assignments, system administration, follow-up, effectiveness evaluation, and qualification or competency requirements.

• Act as a subject matter expert for document management, change control, deviations, CAPA, quality risk management, training, and records management.

• Create and maintain QMS metrics and trends; compile and report departmental quality metrics; assist in management reviews and assessments of QMS effectiveness.

• Utilize ISO 9001 principles to integrate and manage relevant company-wide policies and processes within the QMS.

• Identify and implement opportunities to streamline and enhance quality system processes while ensuring compliance and control.

• Facilitate process improvement, standardization, workflow optimization, continuous improvement, and operational excellence.

• Ensure inspection and audit readiness by keeping quality system documentation, records, and training information complete, current, organized, and retrievable.

• Assist with computerized system validation activities and may take primary responsibility for the computerized system validation program.

• Adapt to evolving organizational needs by flexing across various Quality responsibilities.

⛳️ Requirements

• Bachelor’s degree in life sciences, quality, engineering, or a related field.

• At least 10 years of progressive experience in pharmaceutical or biotechnology quality, with significant direct experience in managing quality management systems.

• Practical experience with electronic QMS administration, document and records management, GxP training, change control, deviations, CAPA, and other essential QMS processes.

• Proficiency in applying ISO 9001 principles and understanding quality management system requirements.

• Familiarity with controlled documents and GxP record types, including metadata, classification, retention, lifecycle management, and retrieval.

• Experience in developing and managing role-based training matrices and administering GxP training programs.

• Strong knowledge of GxP principles and substantial GMP experience across pharmaceutical development.

• Exceptional attention to detail, with the ability to establish and maintain logical, consistent structures for documents, records, metadata, and training.

• Strong organizational, problem-solving, prioritization, and time-management abilities.

• Capability to independently manage multiple quality systems activities and work effectively across different functional teams.

• Excellent written and verbal communication skills, demonstrating a collaborative, team-oriented approach.

• Ability to excel in a fast-paced, dynamic environment while remaining adaptable to change and ambiguity.

• A flexible, proactive, and hands-on approach to work.

• Federal E-Verify employment authorization confirmation is required for new hires.

🏝️ Benefits

• Competitive total rewards package.

• Eligibility for annual bonuses.

• Equity eligibility.

• Comprehensive benefits offering.