NC/CAPA Trend & Signal Lead - QIM
About the job QSE7, a Pennsylvania-based consulting firm, is seeking to hire an experienced NC/CAPA Trend & Signal Lead for a contract engagement with a global pharmaceutical manufacturing client. The role sits in the client's Quality Issue Management (QIM) organization and performs trend analysis, signal detection and data analysis for Non-conformance (NC) and Corrective and Preventive Action (CAPA). You will lead the development and implementation of quality-specific surveillance strategies: proactive, customer-focused, systematic detection and evaluation of potential signals from emerging trends in NC/CAPA data. As a key interface with the client's product and business groups, you will make sure signals reach the right people in time to act. This is a hands-on role for an ambitious quality professional with excellent analytical, written and verbal communication skills, working with partners at all levels across multiple functions in an environment that embraces teamwork and risk-based decision-making. This is a remote position. Job Responsibilities: Support the NC/CAPA Global Process Lead to ensure governance of the NC/CAPA quality system receives the KPI metrics, analysis and emerging-risk inputs it needs. Perform process oversight of the end-to-end NC/CAPA process, monitoring execution to confirm overall process health for compliance, business performance and productivity. Lead the design and implementation of quality-specific surveillance strategies, including the criteria used to detect, evaluate and prioritize potential signals. Perform systematic trend analysis and signal detection on NC/CAPA data, applying risk-based judgment to separate true signals from noise. Dive deep into the data while communicating high-level findings and recommendations through expert analysis. Partner with business stakeholder groups (QM&D, Supply Chain, R&D, Commercial Quality and External Quality) through governance forums to review actionable signals from NC/CAPA analysis. Serve as a key interface with product and business groups to ensure awareness of signals and drive follow-up actions. Build and maintain dashboards, reports and analytical models that make NC/CAPA trends and KPIs visible to stakeholders. Provide support during audits and inspections by extracting appropriate NC/CAPA data sets and analysis. Recommend process improvements where monitoring reveals gaps, bottlenecks or adverse trends.
Qualifications
Bachelor's degree in Life Sciences, Engineering, Statistics, Data Analytics or a related field. 7+ years of experience in Quality, Compliance or Operations in GxP-regulated pharmaceutical, biotech, medical device or consumer health environments. Hands-on experience with Non-conformance and CAPA processes, including investigation, root cause analysis and effectiveness checks. Demonstrated experience performing trend analysis and translating data into actionable insights for business stakeholders. Working knowledge of GMP and relevant regulations and standards (e.g., 21 CFR Parts 210/211 and 820, ISO 13485, ICH Q9 and Q10). Advanced proficiency in Excel and at least one data visualization tool; Power BI strongly preferred (Tableau or Spotfire also considered). Familiarity with statistical methods for signal detection, such as control charts and SPC, is a plus. Experience with eQMS platforms (e.g., Veeva Vault QMS, TrackWise, MasterControl) preferred. Experience with SQL, Python or R for data extraction and analysis is a plus. Direct support of audits or regulatory inspections. ASQ (CQE, CQA) or Six Sigma certification is a plus. Strong communication skills, with the ability to present complex findings simply to audiences from front-line teams to senior leadership. Self-directed, customer-focused and able to influence across functions without direct authority. About QSE7 - Founded in 2016, QSE7 offers innovative and specialized IT and Consulting services to FDA-regulated life sciences companies. Our areas of focus include program/project management, process analysis, automated business process improvements, data analytics and reporting, and implementation of IT solutions based on Microsoft technologies, such as Excel, MS Teams, SharePoint, Power BI and Power Automate. We strive to bring automation and efficiency to our clients' processes by providing high-quality and intuitive solutions in an efficient, comprehensive manner.