Boehringer Ingelheim Medical Compliance Lead 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.
The Medical Compliance Lead is a lead role, proficient in GCP/ICH requirements, key risks within Quality Management System as well as processes related to Medicine functions. This position will be responsible for identifying risk and failure points within a system and process, establish a solution, and the conduct of error analysis. In addition, this position would lead solutions and recommendations across Medicine in risk mitigation and drive sustainability solutions. This position will also support the implementation of Quality Management principles (Quality by Design - QbD, Quality Risk Management - QRM- and Quality Management System- 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:
Lead US QM Compliance associates, tasks and support the activities andprojects in Quality Medicine assigned and under the direct supervision of theHead of US Medical Compliance. Act as adeputy of the Head of US MedicalCompliance when required.
Serve as the point of escalation within QM functions (e.g.: auditingteam) and business partners to assure compliance with process and systems.Serve as a leader by assisting BIPI with consultancy on quality/regulatoryissues.
Develop and lead the implementation of Key performance indicators (KPIs)and Key Quality indicators (KQIs) based on initiatives and process improvementsefforts. Analyze continuously trends, thresholds and risk impact of qualityevents that are escalated to QM and provide reports on a frequency to bestipulated. Lead and contribute to Quality Management activities and projectssuch as the development, implementation, training and maintenance of QualityImprovement plans based on audit reports, priorities and CAPA investigationsand follow up to identify areas of improvement and compliance risk.
Lead cross functional quality projects with complete autonomy.
Serve as inspection lead/coordinator for USA FDA /health authorityinspections at BIPI, facilitating the interactions between inspector andBI. Provide feedback and guidance oninspection preparation activities. Serve as Primary Contact Person (PCP) an allinspections preparations activities.
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 topicsidentified 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 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.
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.
Perform external visits (if necessary) to assure adherence on GCP and FDAregulatory requirements including visits to strategic alliance partners.
Bachelor’s Degree (of Science) from an accredited institution, orequivalent in scientific or health related field.
A minimum of eight (8) years progressive in clinical regulatorycompliance experience including a broad range of GCP auditing and/or clinicalcompliance experience/demonstrated experience in a senior advisory role.
Leadership and analytical skills, ability to change, adaptability, self-motivation,lateral thinking and Initiative.
Requires exclusivity of responsibility, strategic and operational processesconceptual/analytical thinking, internal accountability and organizationaldesign.
Desired Skills, Experience and Abilities:
- Master’s degree from an accredited institution preferred.
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 Lead
Requisition ID: 1814572