External Quality Operation Manager (hybrid - NC)

Company Description At Sobi, we believe diversity drives innovation and inclusion creates stronger teams. We are committed to building a workplace where everyone feels valued and empowered to contribute. If this role excites you but you’re unsure if you meet every requirement, we encourage you to apply. Your unique perspective and experiences could be exactly what we need. Job Description The External Operation Manager (EQOM) is responsible for a wide range of activities related to the quality oversight of external suppliers in charge of manufacturing activities for a product. Acting as a single point of contact with the external supplier, the EQOM ensures compliance with current GMP & GDP regulations, the Quality Technical Agreement, and Sobi procedures and policies to support product supply and Sobi’s growth. The role also manages the quality interface and cross‑functional relationships with Sobi stakeholders. Please note that this is a hybrid role – candidates must be located within commuting distance to our Morrisville, NC office and be able to work in the office 50% of the time. Key Responsibilities Act as the 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, and relevant CGMP regulatory requirements for handling, manufacturing, and distribution of products. Support product release by QP delegate according to delegation documents when necessary. Support CMO qualification. Establish and maintain a valid Quality Technical Agreement, clearly defining roles and responsibilities between Sobi and the external supplier. Implement and maintain Quality Risk Assessment and KPIs for external activities; define and monitor remediation plans to address issues and drive improvement opportunities. Ensure 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, and complaints) in accordance with the QTA and Sobi requirements. Manage change requests from CMO or Sobi according to the QTA and Sobi requirements. Support CMO quality audits performed in accordance with Sobi requirements and the QTA. Define strategy for implementing and monitoring key quality transformation initiatives, aligning with all process stakeholders outside the Quality organization. Act as Quality representative in projects related to CMO such as tech transfer and launch. Assess and ensure CMO readiness for Health Authority inspections. Support Health Authority inspections/audits of Sobi. Inform line manager and cross‑functional teams of all critical and major issues and escale issues per Sobi escalation policy. Maintain good collaboration within Global Quality Operations and cross‑functionally. Qualifications Required University degree or equivalent in pharmaceutical, biotech, or life science. More than 5 years of experience in the pharmaceutical, biotech product sector, including QA operations, production, or other relevant GMP/GDP functions. More than 1 year of experience managing external quality oversight of CMOs. Curriculum coverage of batch release qualification requirements. Desired More than 2 years of experience in a global operations environment with English as a 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 The base salary range for this role is $115,000–$140,000 . Each individual offer will be determined based on experience, qualifications, and location. The role is eligible for short‑term and long‑term bonuses as outlined in the plan details. Benefits Competitive 401(k) match. Tuition and wellness reimbursements. Comprehensive medical, dental, and vision package. Additional recognition awards. Equal Opportunity Employer Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex, age, physical, mental or sensory disability, HIV status, sexual orientation, gender identity, protected veteran status, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected group by the laws or regulations in the locations where we operate. To request a reasonable accommodation if you are a qualified individual with a disability or a disabled veteran, please email View email address on click.appcast.io. #J-18808-Ljbffr Sobi - Swedish Orphan Biovitrum AB (publ)