Associate Director, Quality System, QMS

Job Functions/Responsibilities

• Lead the end-to-end implementation and rollout of new modules within VeeVa, ensuring alignment with business needs and regulatory requirements.
• Serve as the Quality Systems lead and subject matter expert (SME) processes, driving standardization and harmonization across the organization.
• Partner with cross-functional stakeholders (Quality Assurance, Manufacturing, Supply Chain, and IT) to define system requirements, workflows, and business processes.
• Oversee system configuration, user acceptance testing (UAT), and validation activities (e.g., CSV/CSA) to ensure the system is fit for intended use and compliant with global GMP regulations.
• Auxiliary in developing and executing implementation plans, including timelines, resource planning, risk mitigation strategies, and communication plans.
• Author and/or review governing documents (SOPs, work instructions, and training materials) to support the new modules and ensure alignment with QMS requirements.
• Lead training strategy and rollout, including role-based curricula, to ensure successful user adoption and adherence to new processes.
• Monitor system performance and user feedback post-implementation; identify and implement continuous improvements and enhancements.
• Collaborate with internal stakeholders to ensure alignment and effective utilization of newly implemented and current modules.
• Act as the primary point of contact for system-related issues, deviations, and change controls.
• Support internal and external audits and health authority inspections by providing system documentation, demonstrating functionality, and addressing inquiries.

Qualifications

• Education / Experience: Bachelor’s degree in scientific discipline, 12+ years’ experience and strong background in Quality and Quality Systems in the drug development industry with knowledge of cGMP/ICH/FDA/EMA regulations.
• Prior experience implementing or supporting electronic QMS platforms, ideally VeeVa Vault QMS.
• Strong project management and change management skills is a plus.
• Demonstrate a quality mindset and ability to influence across the organization.
• Successful experience writing and reviewing SOPs and other Quality documents.
• Expert knowledge of phase appropriate cGxPs and experience leading Quality System implementation and continuous improvement efforts.
• Demonstrated ability to successfully interact with regulatory health authorities at inspections and thorough understanding of audit and vendor management programs.
• Excellent organizational skills: Proactive, management of multiple tasks of varying complexity simultaneously.
• Strong interpersonal skills including relationship building, conflict resolution, and verbal and written communication are essential in this collaborative work environment.