Edwards Lifesciences Sr. Manager, Global Clinical Compliance THV in Irvine, California
The THV clinical organization is a multi-functional team supporting the product development lifecycle through groundbreaking clinical trial design and execution from first in man through post market surveillance, leading clinical evidence in THV worldwide.
As the Sr Manager of Global Clinical Compliance, you will lead the development, implementation, and continuous improvement of Clinical Compliance processes.
Develop and manage global comprehensive BU clinical compliance processes and workflows to ensure clinical compliance in accordance with regulatory and company requirements.
Lead internal cross-functional compliance assessments focusing on adherence with applicable global regulatory and company guidelines (e.g., internal Standard Operating Procedures and Instructions, GCP, and best practices.) Investigate and identify any risk areas within Clinical Affairs (and Medical Affairs as applicable) and provide recommendations for process improvements.
Identify, lead, and provide global business improvement solutions for Clinical study processes, including creating, reviewing, and recommend changes to procedures and processes to improve operation, efficiencies, and drive clinical compliance.
Lead strategic discussions and determine preventative actions on risk area(s) with stakeholders while leading the implementation of broad and more complex strategies, including advising internal and external stakeholders.
Develop appropriate corrective actions in partnership with the cross-functional audit finding owners promptly in accordance with applicable regulatory and company guidelines.
Lead compliance assessments of external research partners (e.g., research institutions, clinical vendors). Develop and lead the global implementation of corrective action in partnership with stakeholders (e.g., clinical research, vendor management, clinical safety).
Develop a program for the ongoing review of external regulatory audit findings (e.g., FDA warning letters, 483's, CAPA) and conduct risk assessments and provide recommendations for corrective actions.
Bachelor's Degree, twelve years' previous Clinical and or Quality Compliance experience Required.
Master's Degree, ten years' experience Required.
Experience working in a large manufacturing company Preferred.
Proven successful project management skills preferred.
Recognized as an expert in own sub-function(s) and/or area(s) within the organization with broad-based advanced knowledge within the organization.
Expert understanding of related aspects of Clinical Compliance processes and/or systems.
Expert knowledge and understanding of diverse and applicable regulations and standards relevant to medical devices.
Excellent documentation and communication skills and interpersonal relationship skills, including negotiating and relationship management skills with the ability to drive achievement of objectives.
Ability to manage competing priorities in a fast-paced environment
Expert knowledge and understanding of regulatory requirements for new products or product changes.
Expert knowledge of clinical trials and quality systems (e.g., root cause analysis, trend analysis, and CAPA).
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.