External Quality Operation Manager hybrid NC

External Quality Operation Manager (hybrid - NC) Full-time Sobi Location: United States Job Overview We are seeking an External Quality Operation Manager (EQOM) to drive quality oversight of external suppliers manufacturing our products. This hybrid role requires candidates to be located within commuting distance to Morrisville, NC, and to work in the office 50 % of the time. Key Responsibilities Serve as single point of contact for all quality‑related activities at the Contract Manufacturing Organization (CMO). Ensure compliance with Sobi quality system, the Quality Technical Agreement (QTA), and relevant CGMP regulations in handling, manufacturing, and distribution of products. Support product release by the QP delegate per delegation documents when necessary. Support External Service Provider (CMO) qualification. Establish and maintain a valid QTA that clearly defines roles and responsibilities between Sobi and the external supplier. Implement and maintain Quality Risk Assessment and KPIs for external quality activities; define and monitor remediation plans and drive improvement opportunities. Ensure the CMO provides product reviews or data (APQR/PQRs, stability reports) as specified in the QTA and assess product and process performance per Sobi requirements. Manage and approve quality issues (deviations, CAPA, complaints) per QTA and Sobi requirements. Manage change requests from the CMO or Sobi according to the QTA and Sobi requirements. Ensure quality audits of the CMO are performed per Sobi requirements and the QTA. Define strategy for implementation and monitoring of key quality transformation initiatives and align with all process stakeholders outside of the quality organization. Act as quality representative in projects related to the CMO (e.g., technology transfer, launch). Assess and ensure CMO readiness for Health Authority (HA) inspections. Support HA inspections/audits of Sobi. Inform line manager and cross‑functional teams of all critical and major issues and escalated per Sobi escalation policy. Maintain collaboration within Global Quality Operations and cross‑functionally. Qualifications Higher education (university degree or equivalent) in pharmaceutical, biotech, or life sciences. More than 5 years of experience in the pharmaceutical/biotech industry, QA operations, production, or related area (GMP, GDP). More than 1 year managing external quality oversight of CMOs. Experience evaluating batch release qualification requirements. More than 2 years working in a global operations environment with English as the main language. Proven experience leading quality KPI assessment and improvement at CMOs. Proven track record with FDA, EMEA, or other Health Authorities. Strong understanding of risk assessment and risk management fundamentals/tools. Fluently spoken and written English. Compensation and Total Rewards Base salary range: $115,000 – $140,000. Additional short‑term and long‑term bonuses. Benefits include: Competitive 401(k) match. Tuition and wellness reimbursements. Comprehensive medical, dental, and vision package. Equal Opportunity Employer Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, color, religion, gender, age, physical or mental disability, sexual orientation, gender identity, protected veteran status, or any other status protected by law in the locations where we operate. If you are a qualified individual with a disability or a disabled veteran, you may request reasonable accommodation by emailing View email address on click.appcast.io. #J-18808-Ljbffr Sobi