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Medical Compliance Expert

Description:   This position should be considered an expert with regards to GXP (specifically in the GCP area. The US Medical Compliance Expert serve as a lead in ensuring improvement and maintenance of Clinical Compliance processes within BIPI Medicine and clinical research activities in compliance with GCP, ICH guidelines, FDA regulations and internal processes. The US Medical Compliance Expert also leads the investigation related to quality events with the ability to analyze data, understand Root Cause Analysis, CAPA processes and outcomes, and drive continuous process improvement related to issue management.   This position will also lead the implementation of Quality Management principles (QdB, QRM and QMS) within BIPI Medicine and should work together with business professionals to embed QbD in clinical development and clinical trials execution from study planning through completion.   As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees   Duties & Responsibilities: Serve as a lead in driving activities and projects involving US Compliance in Quality Medicine aligned with the scope of the project. Demonstrate strong knowledge and understanding of BI Quality Manual, Standard Operating Procedures, applicable regulatory requirements (FDA, ICH & country specific), and current industry standards and practices. Serve as a US Compliance Lead on investigations by closely interacting with key stake holders in developing and delivering against corrective and preventive actions. Provide expert guidance to BIPI Business functions and Therapeutic areas on root cause analysis. Serve as inspection coordinator for USA FDA /health authority inspections at BIPI, facilitating the interactions between inspector and BI.  Provide feedback and guidance on inspection preparation activities. Serve as Primary Contact Person (PCP) an all inspections preparations activities. Serve as a primary contact to Medicine Leadership Team (MLT) and Senior BIPI leaders related to inspection updates, debriefs, Health Authorities responses, etc. Serve as a US Compliance SME by attending departmental, staff and any other meetings where clinical compliance input is advisable and supported by Quality Management principles. The interaction with BI Therapeutic areas is expected with full understanding on target diseases, pipeline and protocol design. In addition, prepare and proactively present on selected topics identified as trends, critical and major quality events, information sharing, processes updates at management meetings within Medicine. Lead the interpretation of trends associated with key therapeutic areas responsibility. Analyze continuously trends, thresholds and risk impact of quality events that are escalated to QM by using QbD and QRM approach by employing analytical and risk-management methodology. Lead and contribute to Quality Management systems and projects such as the development, implementation, training and maintenance of Quality Improvement plans based on audit reports, priorities and CAPA investigations and follow up that identify areas of improvement and compliance risk. Perform external visits (if necessary) to assure adherence on GCP and FDA regulatory requirements including visits to strategic alliance partners. Serve as liaison to across sub-functions and business partners to assure compliance with process and systems. Requirements: Bachelor's Degree (of Science) from accredited institution or equivalent in scientific or health related field Ability to understand/interpret/coordinate quality and performance improvement activities, perform data collection and reporting, and support compliance and risk management activities. This position requires an innovative and strategic leader to drive the implementation of new processes across QM and Medicine functions. A minimum of five to seven (5-7) years progressive clinical regulatory compliance experience including a broad range of GCP auditing and/or clinical compliance experience/demonstrated experience in a senior advisory role. Expertise in regulatory requirements in the area of GCP, ICH guidelines and FDA regulations. Ability to operate independently of functional groups and provide critical independent assessments and advise to senior management. Strong analytical skills as well as demonstrated strength in agility while demonstrating initiative and ability to develop and implement a new process. Exclusivity of responsibility, strategic and operational processes conceptual/analytical thinking, internal accountability, organizational design, initiative and self-motivation. Desired Skills, Experience and Abilities: Master's Degree from an accredited institution preferred.                          Eligibility Requirements: Must be legally authorized to work in the United States without restriction. Must be willing to take a drug test and post-offer physical (if required) Must be 18 years of age or older
Salary Range: NA
Minimum Qualification
5 - 7 years

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