Sr. AD, Quality & Compliance Lead

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 an opportunity for all employees to collaborate internationally, offering visibility and the opportunity to directly contribute to the company's success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance.

Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

The SR AD, US Quality and Compliance Lead (QCL) is the Quality and Compliance expert and drives GvP / GcP topics across the BI organization to proactively manage Quality and Compliance across the drug/device lifecycle. This role leads the organization to identify and mitigate risks throughout the drug/device lifecycle to ensure patient safety and data integrity. The position holder initiates and manages any quality and compliance topics to continuously improve our Quality Management System.

The SR AD, US QCL provides quality and compliance consultancy to enable fast and efficient research and development, market authorizations and maintain licenses for our portfolio of products within BI US. This role contributes US insights into the Global Quality Medicine Strategy and executes the strategy at US level with the ability to act locally and think globally.

• Executes the supplier management tasks and activities (qualification, oversight and termination activities) for the assigned suppliers in their region, as per global process.
• Contributes holistic Quality and Compliance input as a Project Quality and Compliance Lead (PQCL) at the project/trial level, provided appropriate qualification is available and under the oversight of global.
• Develops and maintains the global Quality Management System and tailors to the US OPU to comply with local regulatory requirements.
• Leads with the Head of QM the preparation of Quality Management Review reports and meetings
• Actively collaborates in the set-up, development and implementation of quality objectives and Quality plans.
• Deputize for the US Head of QM where applicable.
• Is a quality & compliance consultant and works collaboratively as a solution oriented, pragmatic partner to the Medicine functions and other applicable business partners, leading them to understand the quality and compliance requirements and implications for their business area.
• Assesses impact of Regulatory Intelligence Network (RIN) changes on Quality and Compliance processes and acts and escalates topics accordingly.
• Leads the understanding of Quality Culture by ensuring quality and compliance standards are understood and embedded into processes and practices early (Quality by Design).
• Responsible for active involvement and participation in local/ global/regional activities/topics and projects.
• Leads the implementation and maintenance of global procedures in a pragmatic, clear and concise way and ensure adherence to the local regulatory and business requirements.
• Collaborates with Experimental Medicine and BU Medicine functions in conducting US learning needs analysis (training, qualification).
• Communicates global changes into US as required to enable adoption of the new ways of working.
• Verifies translation of relevant topics as required.
• Initiates updates of relevant process descriptions and guidelines as needed.
• Leads FDA and other global or local authorities inspections end to end (inspection preparation, conduct and post inspection management), representing the BI compliance position to regulatory authorities during inspections ensuring inspection findings are addressed and responses provided.
• Ensures lessons learned are implemented.
• Contributes to audits by inputting into the annual audit planning and ensures audit findings are appropriately investigated and actions are effectively implemented.
• Conducts audit activities as lead-; co- or BI responsible auditor provided appropriate qualification is available, upon…