Job DescriptionPurpose The Senior Manager - eQMS (electronic Quality Management System) Technologies is responsible for enabling data-driven quality and compliance decisions across the enterprise by developing and deploying advanced analytics, AI-enabled insights, and measurement solutions. This role partners with Quality, Business Technology Services (BTS), and process owners to define and execute the quality data strategy, improve data quality and accessibility, and deliver dashboards, metrics, and advanced analytics/AI that support continuous improvement, and global regulatory compliance. The position helps ensure effective quality insights and services are in place across R&D to support more informed decision making, and proactive risk management in accordance with applicable policies, processes, procedures, and global regulatory requirements.
Responsibilities - Support the development and execution of quality analytics and AI roadmaps aligned with RDQA, R&D, and Enterprise Quality priorities.
- Build and maintain automated reporting, dashboards, and KPI frameworks to monitor quality processes and eQMS health, performance, and compliance.
- Develop advanced analytics and AI capabilities (e.g., trend, anomaly, and predictive risk signals) to identify quality and compliance risks earlier.
- Partner with process owners and BTS to translate business needs into analytics requirements, data products, and insight-driven actions.
- Establish data definitions, quality controls, and governance for key quality datasets and metrics.
- Enable self-service use of dashboards and insights through training, playbooks, and documentation.
- Review and approve SLC documentation to support compliant use of data and models in regulated environments.
- Assess the adoption, impact, and performance of analytics solutions; apply feedback, statistical methods, root cause analysis, and data storytelling to drive continuous improvement.
Qualifications- Required:
- Bachelor's Degree in Pharmacy, Engineering, Computer Science, Data/Analytics, Business, Chemistry, Biology, Microbiology, or relevant course of study
- 5-7 years of experience in quality systems, engineering, data/analytics, or business support in a regulated environment
- Demonstrated experience developing metrics, dashboards, and analytical insights for process performance and compliance monitoring
- Working knowledge of data fundamentals (data modeling, data quality, governance) and analytical methods (descriptive/inferential statistics, trend analysis)
- Preferred:
- Experience with BI and analytics tooling (e.g., Power BI or similar) and query languages (SQL); scripting/analysis in Python, R or similar is a plus
- Experience applying machine learning/AI techniques to operational quality problems (e.g., risk prediction, signal detection, text analytics) and understanding of model lifecycle considerations (monitoring, bias, drift)
- Experience implementing or enhancing computerized QA/eQMS solutions with a focus on data enablement and insights
- Knowledge of tools and techniques that can be leveraged into actionable activities and influence decision making
- 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
Additional InformationApplicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
