Senior Quality Compliance Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the daily operations of the Quality Intelligence Center (QuIC) and lead a skilled team responsible for monitoring quality at the portfolio level.

• Take ownership of and enhance the QuIC operating model, which includes the review schedule, signal triage, documentation standards, escalation pathways, action tracking, and governance processes.

• Set up review schedules and business standards for assessing dashboard outputs, quality metrics, trends, anomalies, threshold breaches, and other signals generated by QuIC.

• Direct the review and prioritization of quality signals to pinpoint issues that necessitate evaluation or further action.

• Convert deviations, CAPAs, audit and inspection findings, operational metrics, and associated evidence into governance-ready summaries, recommendations, and escalation reports.

• Document, escalate, and guide significant findings to the responsible process owners and cross-functional stakeholders.

• Define and recommend QuIC business rules, operational standards, documentation expectations, escalation pathways, and workflow requirements.

• Collaborate with R&D Quality, Global Development Operations, and other stakeholders to ensure that QuIC insights are comprehended and acted upon.

• Spearhead process enhancements and provide business leadership for QuIC upgrades, which include signal definitions, thresholds, business rules, data-quality expectations, training, and adoption initiatives.

• Track the effectiveness, timeliness, quality, and capacity of oversight activities and implement practical improvements.

• Ensure all activities adhere to applicable GxP, quality system, data governance, and internal procedural requirements.

⛳️ Requirements

• Doctorate degree with 2 years of Quality experience OR Master’s degree with 4 years of Quality experience OR Bachelor’s degree with 6 years of Quality experience OR Associate’s degree with 10 years of Quality experience OR High school diploma / GED with 12 years of Quality experience.

• Bachelor’s degree in a scientific, clinical, quality, data, or related field, with substantial relevant experience in R&D Quality, clinical development, clinical operations, quality systems, risk management, or centralized monitoring.

• Proven experience in leading and developing professional staff or managing complex cross-functional teams.

• Ability to interpret quality, operational, or risk data and translate findings into actionable recommendations, escalations, and follow-up actions.

• Familiarity with GCP, quality-risk management, issue management, CAPA and deviation processes, audit and inspection readiness, and quality governance.

• Experience as an R&D Quality process owner or overseeing quality across deviations, CAPAs, audits, inspections, management reviews, or risk-management processes.

• Background in QMS platforms, dashboards, data visualization, data quality, business analysis, user acceptance testing, or digital product implementation.

• Knowledge of risk-based quality management, centralized monitoring, KRIs, QTLs, CSM, or signal-based quality oversight.

• Experience with AI-enabled analytics or digital quality products, including the critical evaluation of system-generated insights and the application of human judgment.

• Proven track record of leading operational change in a global matrix environment.

• Sponsorship for this role is not guaranteed.

🏝️ Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions.

• Group medical, dental, and vision coverage.

• Life and disability insurance.

• Flexible spending accounts.

• Discretionary annual bonus program.

• Stock-based long-term incentives.

• Award-winning time-off plans.

• Flexible work models where possible.

• Career development opportunities.

• Support for work/life balance.