Execute on supplier qualification activities, such as Supplier Corrective Action Requests, performing supplier audits, and writing audit reports; interact with lab operations personnel to ensure compliance with company quality systems policies and procedures.
Drive the development and manage the execution of cross-functional plans for scientific projects and product development including scenario planning, high level forecasting of timelines, project feasibility, estimation of budget and resources, and development of program strategies.
Responsible for defining, creating, developing, implementing, testing, deploying, and running software that supports company's data analysis pipelines, clinical reporting software, and other similar internal products.
Proactively develop, lead and drive the execution of global regulatory strategy and quality oversight for the company; serve as a key and active member of the leadership team, working collaboratively to ensure regulatory and quality objectives are met and aligned with company's objectives.
Use strong project and organizational knowledge, leadership and active facilitation to enable effective team meetings and high-performance teams; develop, maintain, track, and resource, integrated project plans to enable accurate reporting and decision making.
Design and lead company-wide full lifecycle talent acquisition processes.; lead the recruiting team to implement fresh solutions to improve the speed and efficiency of hiring; ensure the team is driving the hiring process with a high sense of urgency.
Responsible for providing medical insight to advance immune-based biomarkers into existing and new products for the company; oversees the medical expertise for company with collaborators and research partners.
Establish annual goals, while ensuring compliant execution of medical affairs activities; includes advancing external collaborations with health care practitioners and research groups, and helping define clinical utility to support payer strategy.