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Senior Data Quality Manager
2 months ago
The Senior Manager, Global Development Quality Management (GCP) acting as a Quality Management Lead (QML) is a key position that will provide guidance and leadership for all aspects of quality and compliance within Global Development Quality (GDQ) systems.
Key Responsibilities- Quality Management: Engage with key stakeholders, build strategic partnerships working and liaising with study teams, relevant functions and other GDQ functions to lead risk-based quality management activities on all Regeneron-sponsored clinical trials, inclusive of issue management and providing continuous support of inspection readiness.
- Subject Matter Expert: Act as a Subject Matter Expert (SME) and key liaison to GDQ to provide support and advise on any quality issues to ensure compliance and for the Quality Risk Assessment process.
- Risk-Based Quality Management: Ensure and responsible for Risk-Based Quality Management (RBQM) initiatives and process improvements, in partnership with other functional areas.
- Quality and Compliance Support: Provide day-to-day quality and compliance support to cross-functional stakeholders, including issue management (triage/investigation/actions), audit responses, proactive quality management, Corrective Action/Preventive Action (CAPA) oversight, audit/issue trending.
- Quality Risk Assessment and Control Tracker: Lead Quality Risk Assessment and Control Tracker (QRACT) activities at the time of Protocol development predicated on ICH E6 R2.
- Compliance and Training: Provide consultation, mentorship, training, and support in respect to compliance with applicable international regulations, practices, and guidelines.
- Issue Escalation: Advise on the escalation of any quality issues that potentially represent serious non-compliances (or serious breach) via the issue escalation process.
- Data Collection and Reporting: Support the collection and reporting of data (e.g.,).
- Quality Mindset: Exemplify a quality mindset and behaviors in all interactions with internal and external colleagues, serving as an ambassador for GDQ.
- Education: Bachelor's degree with a minimum of 8 years of relevant healthcare/pharmaceutical industry experience.
- Experience: Experience working in either a quality/compliance role (e.g., Quality Management, Quality Assurance etc.),
