External Quality Operation Manager (GMP)

Job Overview Join Sobi’s mission to improve the lives of people with rare diseases by ensuring the highest standards of product quality and patient safety. As an External Quality Operations Manager (EQOM), you’ll play a pivotal role in overseeing the quality performance of external manufacturing partners, acting as the primary point of contact for these suppliers and ensuring that every batch produced meets GMP/GDP requirements, aligns with Quality Technical Agreements, and upholds Sobi’s global quality standards. You will serve as the bridge between Sobi and its external network, driving compliance, collaboration, and continuous improvement to support reliable product supply and Sobi’s fast‑growing global footprint. This role offers the opportunity to work cross‑functionally with Manufacturing, Supply Chain, Technical Operations, and Regulatory Affairs, strengthening Sobi’s commitment to delivering high‑quality medicines to patients worldwide. Benefits Competitive compensation for your work Generous time off policy Opportunity to broaden your horizons by attending popular conferences Emphasis on work/life balance Collaborative and team‑oriented environment Making a positive impact to help ultra‑rare disease patients who are in need of lifesaving treatments 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 effective Quality Technical Agreement (QTA) and relevant CGMP regulatory requirements across handling, manufacturing, and distribution of products. Support release of products to markets. Support the External Service Provider (CMO) Qualification. Establish and maintain a valid QTA, clearly defining roles and responsibilities between Sobi and the External Supplier. Implement and maintain Quality Risk Assessment and KPIs on Quality External activities; guide remediation plan development and monitoring. Lead or act as Quality representative in projects related to CMO, such as Tech Transfer and Launch. Ensure CMO provides product reviews or data (APQR/PQRs, stability reports) as specified in the QTA; assess product and process performance per Sobi requirements. Manage/approve quality issues (deviations, CAPA, complaints) per QTA and Sobi requirements. Manage change requests from CMO or Sobi in accordance with the QTA and Sobi requirements. Support CMO quality audits performed according to Sobi requirements and the QTA. Define strategy and monitor key Quality transformation initiatives, aligning with all process stakeholders outside of the Quality organization. Assess and ensure CMO readiness for Health Authorities (HA) inspections. Support HA inspections/audits of Sobi. Inform line manager and cross‑functional teams of all critical and major issues and elevate issues as per Sobi escalation policy. Maintain good collaboration within Global Quality Operations and cross‑functionally. Ensure batch release as required. Qualifications Required: University degree or equivalent in pharmaceutical, biotech or life science. More than 5 years of experience in pharmaceutical or biotech product, QA operation, production or other relevant area (GMP, GDP). More than 1 year of managing external quality oversight of CMOs. Experience evaluating batch release qualification requirements. Fluent spoken and written English. Desired: More than 2 years of working in a global operation 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. What You’ll Bring To thrive in this role, you’ll combine deep knowledge of GMP and GDP regulations with proven experience in quality oversight of Contract Manufacturing Organizations (CMOs). You’re confident operating in a global, fast‑moving environment, using your leadership and interpersonal skills to influence external partners and drive collaborative decisions. You naturally build strong relationships—both within Sobi and with CMOs—and balance compliance with practical solutions that keep supply moving. Highly organized and skilled in planning and prioritization, you coordinate multiple deliverables with precision. As a leader, you take pride in coaching and developing others, fostering a culture of accountability and high performance across the quality network. Compensation and Total Rewards The base salary range for this role is $130,000–$153,000. Each individual offer will be determined based on several factors, including your experience, qualifications and location. Additionally, this role is eligible for both short‑term and long‑term bonuses, as outlined in the plan details. 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 (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans and/or expression, marital, 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 groups by the laws or regulations in the locations where we operate. #J-18808-Ljbffr Sobi - Swedish Orphan Biovitrum AB (publ)