External Quality Operation Manager (GMP)

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, you’ll ensure that every batch produced meets GMP/GDP requirements, aligns with Quality Technical Agreements, and upholds Sobi’s global quality standards. Key Responsibilities Act as single point of contact for all quality related activities at the Contract Manufacturing Organization (CMO). Ensure compliance of handling, manufacturing, and distribution with Sobi Quality system, QTA, and CGMP regulatory requirements. Support release of products to Markets. Support External Service Provider (CMO) Qualification. Establish and maintain Quality Technical Agreements with clear roles and responsibilities. Implement and maintain Quality Risk Assessment and KPIs on external activities; guide remediation plans and support continuous improvement. Ensure CMO provides required product reviews or data (APQR/PQRs, stability reports) as specified in the QTA and assess performance per Sobi requirements. Manage and approve quality issues (deviations, CAPA and complaints) as per QTA and Sobi requirements. Manage change requests from CMO or Sobi in accordance with QTA and Sobi requirements. Ensure CMO quality audits are performed according to Sobi and QTA requirements. Define strategy for key quality transformation initiatives and align with external stakeholders outside Quality organization. Represent Quality in projects related to CMO such as tech transfer, 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 critical and major issues and ensure escalation per Sobi escalation policy. Maintain collaboration within Global Quality Operations and cross‑functional groups. 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 operations, production or related areas (GMP, GDP). More than 1 year of managing external quality oversight of CMOs. Knowledge of batch release qualification requirements. Fluent spoken and written English. Desired: More than 2 years experience in a global operations environment with English as main language. Proven experience leading quality KPI assessment and improvement at CMOs. 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 leadership and interpersonal skills to influence external partners and drive collaborative decisions. You build strong relationships, balance compliance with practical solutions, and coordinate multiple deliverables with precision. As a leader, you coach and develop 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 factors such as experience, qualifications, and location. The role is eligible for 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, age, physical, mental or sensory disability, HIV status, sexual orientation, gender identity, protected veteran status, 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. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request reasonable accommodations by sending an email to View email address on click.appcast.io #J-18808-Ljbffr Sobi - Swedish Orphan Biovitrum AB (publ)