Boehringer Ingelheim Medical Compliance Expert in RIDGEFIELD, Connecticut
Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment which benefits our employees, patients and communities.
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 USCompliance 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 interactingwith key stake holders in developing and delivering against corrective andpreventive actions. Provide expert guidance to BIPI Business functions andTherapeutic areas on root cause analysis.
Serve as inspection coordinator for USA FDA /health authority inspectionsat BIPI, facilitating the interactions between inspector and BI. Provide feedback and guidance on inspectionpreparation activities.
Serve as Primary Contact Person (PCP) an all inspections preparationsactivities.
Serve as a primary contact to Medicine Leadership Team (MLT) and SeniorBIPI leaders related to inspection updates, debriefs, Health Authoritiesresponses, etc.
Serve as a US Compliance SME by attending departmental, staff and anyother meetings where clinical compliance input is advisable and supported byQuality Management principles. The interaction with BI Therapeutic areas isexpected with full understanding on target diseases, pipeline and protocoldesign. In addition, prepare and proactively present on selected topics identifiedas trends, critical and major quality events, information sharing, processesupdates at management meetings within Medicine.
Lead the interpretation of trends associated with key therapeutic areasresponsibility. Analyze continuously trends, thresholds and risk impact ofquality events that are escalated to QM by using QbD and QRM approach byemploying analytical and risk-management methodology. Lead and contribute toQuality Management systems and projects such as the development,implementation, training and maintenance of Quality Improvement plans based onaudit reports, priorities and CAPA investigations and follow up that identifyareas of improvement and compliance risk.
Perform external visits (if necessary) to assure adherence on GCP and FDAregulatory requirements including visits to strategic alliance partners.
Serve as liaison to across sub-functions and business partners to assurecompliance with process and systems.
Bachelor’s Degree (of Science) from accredited institution or equivalentin scientific or health related field
Ability to understand/interpret/coordinate quality and performanceimprovement activities, perform data collection and reporting, and supportcompliance and risk management activities.
This position requires an innovative and strategic leader to drive theimplementation of new processes across QM and Medicine functions.
A minimum of five to seven (5-7) years progressive clinical regulatorycompliance experience including a broad range of GCP auditing and/or clinicalcompliance experience/demonstrated experience in a senior advisory role.
Expertise in regulatory requirements in the area of GCP, ICH guidelinesand FDA regulations.
Ability to operate independently of functional groups and providecritical independent assessments and advise to senior management.
Strong analytical skills as well as demonstrated strength in agilitywhile demonstrating initiative and ability to develop and implement a newprocess.
Exclusivity of responsibility, strategic and operational processesconceptual/analytical thinking, internal accountability, organizational design,initiative and self-motivation.
Desired Skills, Experience and Abilities:
- Master’s Degree from an accredited institutionpreferred.
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
Boehringer Ingelheim is one of the world’s top 20 pharmaceutical companies and operates globally with approximately 50,000 employees. Since our founding in 1885, the company has remained family-owned and today we are committed to creating value through innovation in three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing. Since we are privately held, we have the ability to take an innovative, long-term view. Our focus is on scientific discoveries and the introduction of truly novel medicines that improve lives and provide valuable services and support to patients and their families. Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry. We are also deeply committed to our communities and our employees create and engage in programs that strengthen the neighborhoods where we live and work. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA, Inc., Merial Barceloneta, LLC and Boehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmative action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender identity or expression; affectional or sexual orientation; disability; veteran or military status, including protected veteran status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment verifications and drug screenings.
Organization: US-BI Pharma/BI USA
Title: Medical Compliance Expert
Requisition ID: 1814571