External Quality Operation Manager (GMP)
Sobi · Raleigh, NC, United States · Posted Jul 9, 2026
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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 .
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:
Perform as EQOM to act as Single point of contact for all quality related activities at the Contract Manufacturing Organization (CMO)
Ensure that all aspects of handling, manufacturing, distribution of products are in compliance with Sobi Quality system, the effective Quality Technical Agreement (QTA), that they meet relevant CGMP regulatory requirement.
Support release products to Markets
Support the External Service Provider (CMO) Qualification
Ensure Quality Technical Agreement (QTA) be established appropriately and ensure valid QTA clearly defines roles & responsibilities between Sobi and the External Supplier
Ensure implementation and maintaining Quality Risk Assessment and KPIs on Quality External activities. Guide defining & monitoring remediation plans to ensure that issues are suitably addressed. 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 the performance of the product and the process as per Sobi requirement
Manage/approve quality issues (deviations, CAPA and complaints) as per QTA and Sobi requirement
Ensure that Change requests either from CMO or from Sobi are managed according to the QTA and Sobi requirements
Support that Quality Audits of the CMO are performed according to Sobi requirement and the QTA
Lead to define strategy of implementation and monitoring of key Quality transformation initiatives and align with all process stakeholders outside of Quality organization
Lead or act as Quality representative in projects related to CMO eg Tech Transfer, Launch
Assess and ensure CMO for Health Authorities (HAs) inspection readiness
Support HA inspections/audits of Sobi
Responsible to inform the line manager and cross functional teams of all critical & major issues and escalate any issues as per Sobi escalation policy
Ensure a good collaboration is maintained within the Global Quality Operations and cross-functionally
Ensure the batch release as required
Required:
High level education (university degree or similar) within relevant area such as pharmaceutical, biotech or 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 years 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 global operation environment with English as a main language
Proven experience of 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
At Sobi, we are dedicated to providing our 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-$14…