Associate Director, Quality Management Systems

Primary Responsibilities

• Leads the evolution of the QMS into a commercial-ready, globally scalable system aligned with ICH Q10, FDA CFRs, and international regulatory standards
• Ensures QMS processes are phase-appropriate, risk-based, and designed to scale with organizational growth
• Serves as a subject matter expert and primary representative for assigned QMS areas during regulatory inspections and health authority interactions
• Provides strategic and operational leadership for GxP documentation and training programs, ensuring effective use and governance of the eDMS and LMS in support of the quality management system
• Oversees the end-to-end lifecycle management of quality documents, including policies, SOPs, and related controlled records, ensuring consistency, accuracy, and compliance with applicable regulations that achieves inspection readiness
• Drives and manage high-volume document authoring, revision, and implementation – often under accelerated timelines
• Leads the planning, deployment, and governance of role-based training curriculum across functions
• Manages the day-to-day delivery of programs to ensure consistent quality and alignment to employees and their learning goals
• Drives development and review of engaging learning materials/assessments to support learning programs utilizing multiple delivery methods
• Leads technical sessions as needed to scale eDMS/LMS capabilities

Core QMS Program Ownership

• Defines, monitors, and reports quality metrics and KPIs to assess system health, compliance risk, and performance trends
• Drives continuous improvement initiatives to enhance efficiency, reduce risk, and strengthen QMS robustness
• Led the implementation, optimization, and governance of eQMS platforms, ensuring validated systems, strong user adoption, and effective lifecycle management

Operational Excellence & Systems Enablement

• Partners with cross-functional stakeholders to embed quality into business processes and decision-making
• Communicates quality risks, dependencies, and tradeoffs with clarity and urgency, influencing outcomes without direct authority
• Contributes to building a high-performing quality organization and models a culture of accountability, transparency, and continuous improvement

Education And Skills Requirements

• Bachelor’s degree in a scientific discipline or Quality Systems Management; advanced degree preferred
• 8+ years of experience in biotechnology or pharmaceutical environments, with exposure across GxPs (GCP, GLP, GMP, GVP preferred)
• Demonstrated experience with direct ownership of QMS and quality systems
• Deep understanding of global regulatory requirements, including FDA CFRs, ICH guidance, and EU Annex requirements
• Proven experience implementing and managing eQMS platforms (e.g., Veeva eQMS, MasterControl) and Learning Management Systems
• Strong strategic and operational capability, balancing vision-setting with hands-on execution
• Proven ability to manage multiple complex initiatives in a fast-paced, dynamic environment
• Strong judgment and risk management skills, balancing compliance, science, and business needs
• Exceptional written and verbal communication skills with the ability to influence senior and cross-functional stakeholders
• Highly proactive, accountable, and comfortable operating with a high degree of autonomy