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 and projects in Quality Medicine assigned and under the direct supervision of the Head of US Medical Compliance. Act as a deputy of the Head of US Medical Compliance when required.
Serve as the point of escalation within QM functions (e.g.\: auditing team) and business partners to assure compliance with process and systems. Serve as a leader by assisting BIPI with consultancy on quality/regulatory issues.
Develop and lead the implementation of Key performance indicators (KPIs) and Key Quality indicators (KQIs) based on initiatives and process improvements efforts. Analyze continuously trends, thresholds and risk impact of quality events that are escalated to QM and provide reports on a frequency to be stipulated. Lead and contribute to Quality Management activities 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 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 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.
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.
Perform external visits (if necessary) to assure adherence on GCP and FDA regulatory requirements including visits to strategic alliance partners.
BS degree in scientific or health related field or equivalent field of study (MS preferred).
A minimum of eight (8) years progressive in clinical regulatory compliance experience including a broad range of GCP auditing and/or clinical compliance 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 processes conceptual/analytical thinking, internal accountability and organizational design.
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 a different kind of pharmaceutical company, a privately held company with the ability to have an innovative and long term view. Our focus is on scientific discoveries that improve patients' lives and we equate success as a pharmaceutical company with the steady introduction of truly innovative medicines. Boehringer Ingelheim is the largest privately held pharmaceutical corporation in the world and ranks among the world's 20 leading pharmaceutical corporations. At Boehringer Ingelheim, we are committed to delivering value through innovation. 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. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA, Inc. and Boehringer Ingelheim Fremont, Inc. is an equal opportunity employer - Minority/Female/Protected Veteran/Person with a Disability
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.