Head of External Quality North America

Lead and manage the North America (NA) QA functional area, reporting to the Head of External Quality within Global Quality. QA NA is accountable for GMP compliance across Sobi´s external Contract Manufacturing Organization (CMO) network within North America through robust quality oversight including Quality Operations for commercial products. QA NA is also responsible for ensuring optimal efficacy by embracing operational excellence and fostering a culture of continuous improvement by proactively identify and navigate the opportunities and risks inherent in the lifecycle of Sobi products.  QA North America is responsible for maintaining Sobi products are manufactured adherence to GMP standards in NA. The selected candidate will be expected to work onsite at our Morrisville, NC office two days per week as part of a hybrid work schedule. During the onboarding period, the candidate will be expected to be onsite three days per week to ensure a smooth and effective transition into the role.Lead and manage QAs in NA consisting of External Quality Operation managersResponsible for assigning and monitoring appropriate assignment and workload to the direct reportsResponsible for a robust and proactive Quality oversight of CMOs in the region ensuring adherence to all relevant GMP regulations and effective agreementsResponsible for the implementation and maintenance of quality risk assessment (identify, mitigate, manage and communication of risks) and Quality KPIs of CMOsEnsuring QA release of products within area of responsibility in timely mannerResponsible for ensuring timely execution and completion of Quality Operations tasks related to the External network e.g. investigation and approval of Deviations, Complaints, approval of Change control, validation and QTASupport the direct reports for his/her activities at CMO such as GMP inspections, Technical Transfers and other projects where QA is presentedSupport GMP inspections from authorities, when neededEnsure appropriate QA resource utilization to meet supply and demand aligned with internal and external stakeholdersDriving, coordinate and harmonize QA activities within the department and cross-functionally. Improve cycle time & efficiency for key quality processesEnsure effective communication of updates and impact both within own organization, cross-functionally and internal business stakeholders, respectivelyResponsible for the development and management of the functions and people in accordance with the mission, visions, values, and strategic business goalsImplement efficiency improvements, quality development and cost-consciousness in the area of responsibilityActively participate in developing and regular follow-up on the Global Quality External Operation strategic planning initiativesProviding input and being responsible for Global Quality/Global QA External Operations strategic initiativesLead the design, implementation and development of a proactive Quality organization with competencies to ensure reliable development, manufacturing and supply of competitive products and processesPrepare and monitor the budget including resources and maintain adherence to the approved plans