Site Investigations Lead, Quality Assurance

This position is a full-time on-site role (M-F business hours)About This RoleThe Site Investigations Lead (SIL), Quality Assurance, is responsible for championing the overall investigations processes to ensure execution of an effective and compliant process with global and site procedures for the Biogen, RTP, Bio facility. The SIL will have leadership experience and capabilities to influence, impact, and collaborate with all levels of the organization to achieve meaningful outcomes. Responsibilities include but are not limited to: providing quality direction to the business to ensure efficient and effective execution of the exceptions processes, support review and approval of deviations, lab investigations, CAPAs, and change controls for compliance to applicable regulatory and corporate guidance documents, support the generation of metrics, develop and perform training methodologies to improve capability and competency of investigators and approvers, identify gaps and improvements in existing Quality systems and propose and implement solutions.What You’ll DoSupport and approve RTP Bio site exceptions (deviations, lab exceptions, CAPAs) and change controls Serve as the Investigations Subject Matter Expert, supporting the site globally and participating in internal and external inspections Supports resolution of complex technical and compliance issues/gaps of diverse scope Develop and deliver training methodologies to improve capabilities of investigators and approvers Develop, monitor, and review metrics and action plans for investigations program Implement and facilitate meetings and communications related to the investigations program Assist Quality Assurance Management in additional responsibilities related to the day-to-day implementation of the Quality Management Systems required to maintain cGMP compliance, and ensure safety, efficacy and purity of products manufactured by Biogen Additional job duties that may be assigned from time to time