External Quality Operation Manager (GMP)

External Quality Operation Manager (GMP) Full-time Sobi Location: United States Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application! At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients. Our mission and culture at Sobi North America get us excited to come to work every day, but here are a few more reasons to join our team: 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 life saving treatments Join Sobi’s mission to improve the lives of people with rare diseases by ensuring the highest standards of product quality and patient safety. Position Overview 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. You’ll be 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. Key Responsibilities Act as Single point of contact for all quality related activities at the Contract Manufacturing Organization (CMO). Ensure compliance with Sobi’s Quality system and the effective Quality Technical Agreement (QTA), meeting relevant CGMP regulatory requirements. Support release of products to Markets. Support the external service provider (CMO) Qualification. Ensure QTA is established appropriately and clearly defines roles & responsibilities between Sobi and the external supplier. Implement and maintain Quality Risk Assessment and KPI on quality external activities; guide definition & monitoring of remediation plans. Drive or support improvement opportunities for processes and product quality performance. Ensure CMO provides product reviews or data (APQR/PQRs, stability reports) as specified in the QTA; assess performance of product and process per Sobi requirements. Manage/approve quality issues (deviations, CAPA and complaints) per QTA and Sobi requirements. Manage change requests from CMO or Sobi according to QTA and Sobi requirements. Ensure quality audits of the CMO are performed according to Sobi requirement and the QTA. Lead strategy of implementation and monitoring of key Quality transformation initiatives and align with all process stakeholders outside of Quality organization. Act as Quality representative in projects related to CMO tech transfer, launch. Assess and ensure CMO for Health Authorities (HAs) inspection readiness. Support HA inspections/audits of Sobi. Inform line manager and cross‑functional teams of all critical & major issues and escalations per Sobi escalation policy. Maintain good collaboration within Global Quality Operations and cross‑functionally. Ensure batch release as required. Requirements High‑level education (university degree or similar) within a relevant area such as pharmaceutical, biotechor life science. More than 5 years of experience within pharmaceutical, biotech product; experience in QA operation, production or other relevant area (GMP, GDP). More than 1 year of managing external quality oversight of CMOs. Curriculum is requested for evaluating the batch release qualification requirement. Fluently 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 you know how to 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 At Sobi, we are dedicated to providing employees with a comprehensive and industry‑competitive total rewards package. Our compensation philosophy is designed to recognize and reward talent, ensuring that your contributions are valued and reflected in your overall rewards. The base salary range for this role is $120,000–$140,000 . Each offer will be determined by several factors, including 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. 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. 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