Senior Manager, eQMS Technologies

Role Summary

The Senior Manager – eQMS (electronic Quality Management System) Technologies is primarily responsible for quality system activities which include owning and supporting RDQA, R&D, and Enterprise quality systems and applications, supporting business-driven objectives, and leading project work related to quality system implementation, compliance initiatives, analytical tools, and quality metrics. This position helps ensure that effective quality systems and services are in place across R&D to allow 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 dashboards
• 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
• Partner with BTS to drive development of new quality systems and enhancements
• Work with 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 quality systems
• Lead/support continuous quality improvement activities including analytical and metric tools

Qualifications

• Required: Bachelor’s Degree in Pharmacy, Engineering, Computer Science, Business, Chemistry, Biology, Microbiology, or relevant course of study
• 5-7 years of experience in engineering, or quality systems, or business support in a regulated environment
• Preferred: 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
• Travel: Yes, 10% of the Time