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 the External Quality Operations Manager, you will serve as the primary point of contact for external manufacturing partners, ensuring that every batch produced meets GMP/GDP requirements, aligns with Quality Technical Agreements, and upholds Sobi's global quality standards. You will bridge 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.

• 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.
• Support release of products to markets.
• Support CMO qualification and ensure the QTA establishes appropriate roles and responsibilities.
• Implement and maintain Quality Risk Assessment and KPI on external quality activities; guide remediation plans.
• Drive or support improvement opportunities for processes and product quality performance.
• Ensure CMO provides product reviews, data (APQR/PQRs, stability reports) as specified in the QTA and assess performance per Sobi requirements.
• Manage and approve quality issues (deviations, CAPA, complaints) per QTA and Sobi requirements.
• Manage change requests from CMO or Sobi according to QTA and Sobi requirements.
• Support quality audits of the CMO in accordance with Sobi requirements and the QTA.
• Lead the strategy for implementing and monitoring key quality transformation initiatives, aligning with all stakeholders outside the Quality organization.
• Act as Quality representative in projects related to CMO technology transfer and 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 critical and major issues and escalations per Sobi policy.
• Maintain collaboration within Global Quality Operations and cross‑functionally.
• Ensure batch release as required.

• High‑level education (university degree or similar) within a relevant area such as pharmaceutical, biotech or life science.
• More than 5 years of experience within pharmaceutical, biotech product QA operations, production or other relevant area (GMP, GDP).
• More than 1 year of managing external quality oversight of CMOs.
• Curriculum needed for evaluating 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.

To thrive in this role, you will combine deep knowledge of GMP and GDP regulations with proven experience in quality oversight of Contract Manufacturing Organizations (CMOs). You will be 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 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.

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…