Clinical Manager overseeing direct care patient services at CenterWell Home Health locations. Managing clinical operations, caregiver assignments, and compliance in home health care environment.
About the role
- Senior Manager leading quality management activities for Regeneron's clinical trials. Engaging with stakeholders to ensure compliance and support inspection readiness.
Responsibilities
- Acting 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.
- Ensuring and responsible for Risk-Based Quality Management (RBQM) initiatives and process improvements, in partnership with other functional areas.
- Responsible for the management of GCP-compliant activities from a quality perspective in conjunction with the business and the GDQM (GCP) team.
- Providing 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.
- Engaging with, supporting, and liaising with multiple cross-functional stakeholders whose work impacts the GDQ system.
- Leading Quality Risk Assessment and Control Tracker (QRACT) activities at the time of Protocol development predicated on ICHGCP.
Requirements
- Bachelor's degree with a minimum of 8 years of relevant healthcare/pharmaceutical industry experience
- Experience working in either a quality/compliance role (e.g., Quality Management, Quality Assurance etc.), or in a Clinical Development role with expertise and/or transferable skills related to Good Clinical Practice (GCP), and/or Good Pharmacovigilance Practice (GVP)
- Providing consultation, mentorship, training, and support in respect to compliance with applicable international regulations, practices, and guidelines.
- Advising on the escalation of any quality issues that potentially represent serious non-compliances (or serious breach) via the issue escalation process.
- Supporting the collection and reporting of data (e.g., metrics)
- Contributing to and supporting process improvement initiatives and workgroups, as assigned.
- Exemplifying a quality mindset and behaviors in all interactions with internal and external colleagues, serving as an ambassador for GDQ.
Benefits
- health and wellness programs (including medical, dental, vision, life, and disability insurance)
- fitness centers
- 401(k) company match
- family support benefits
- equity awards
- annual bonuses
- paid time off
- paid leaves (e.g., military and parental leave)
Job title
Job type
Experience level
Salary
Degree requirement
Tech skills
Location requirements
Senior Manager driving Pizza Hut's global restaurant development strategy through market planning and site selection collaboration. Key role in expanding business with innovative ideas and strong stakeholder engagement.
Application responsible for managing InvoiceHub systems at Metaline, overseeing system developments and user support.
Alternant BAC+5 Manager de Développement Commercial dans le domaine de l'industrie. Élaborant la stratégie commerciale et managant les équipes commerciales.
Brand Manager responsible for consolidating Blip as a global reference in conversational AI. Focusing on brand strategy and leading multidisciplinary teams to enhance brand perception.
EHS Manager overseeing Environmental, Health, and Safety compliance at Tracy and Fresno sites in California. Leading safety improvements and training initiatives in a manufacturing environment.
Area Manager responsible for expanding relationships in healthcare finance across North Florida and surrounding states. Building partnerships and ensuring effective provider engagement and product adoption.
Manager II, Business Analytics overseeing the operation and development of Adobe Analytics and Launch. Leading teams and consultants to integrate data lakes and strategic analysis for growth opportunities.
Area Manager overseeing community short breaks and domiciliary care services for disabled children. Leading a large team and ensuring compliance with regulations in Shropshire and Warwickshire.
Manager responsible for clean energy asset development and operations at Indiana Michigan Power's portfolio. Leading strategic initiatives for solar, wind, and energy storage resources.