Associate Director, eQMS Technologies

Role Summary

The Associate Director – eQMS (electronic Quality Management System) Technologies is primarily responsible for quality system activities which include: own and support RDQA, R&D, and Enterprise quality systems and applications, support AI and other data-driven functionality, support business driven objectives, and lead project work related to quality system implementation, compliance initiatives, AI, analytical tools, and quality metrics. This position helps ensure that effective quality systems and services are in place across R&D to allow the development of high quality, safe and effective products in compliance with global regulatory requirements and applicable Policies, processes and procedures. These objectives support pharmaceuticals, biologics, combination products and medical devices reporting into the Director, eQMS Technologies.

Responsibilities

• Business system owner (BSO) of validated and more advanced or enterprise computer systems, applications, and data/AI systems
• Review and approve key technical documentation that ensure the compliance of supported systems
• Create and provide training on supported systems
• Work with business partners to ensure the adoption of new systems and continued use of established systems
• Lead and prioritize remediation efforts for any process or technical system issues
• Work and influence internal and external business partners to understand and optimize quality processes that utilize electronic quality management systems
• Develop short-term and long-term strategies that optimize current and future projects.
• Develop and implement quality metrics that demonstrate the health of supported systems
• Lead/support continuous quality improvement activities including analytical and metric tools
• Sponsor technical projects and provide strategic guidance
• Interacts with senior management to recommend technical solutions and analytics for RDQA processes.
• May manage people

Qualifications

• Bachelor‚Äôs Degree-required in Pharmacy, Engineering, Computer Science, Business, Chemistry, Biology, Microbiology, or relevant course of study
• 8-10 years of experience in engineering, or quality systems, or business support in a regulated environment.
• Experience implementing computerized QA Systems and/or metric or analytical tools
• Knowledge of tools and techniques that can be leveraged into actionable activities
• Knowledge of Risk Management principles to help organization focus on the most impactful activities
• Quality Systems knowledge and related experience
• Knowledge of the clinical development for pharmaceuticals and/or medical devices.
• Travel: Yes, 10 % of the Time

Skills

• Quality systems management
• Electronic quality management systems (eQMS)
• Analytical and metric tools
• Project leadership and strategic guidance
• Regulatory compliance and documentation
• Cross-functional collaboration
• Training and knowledge transfer
• Risk management