External Quality Operation Manager (GMP) (West coast based)

Sobi • San Diego, CA

1h • $112,000 - $153,000

About The Position

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.

Requirements

• 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

Nice To Haves

• 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

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 the release products by QP Delegate according to delegation documents, when necessary
• 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

Benefits

• A competitive 401(k) match to support your financial future.
• Tuition and wellness reimbursements to invest in your personal and professional growth.
• A comprehensive medical, dental, and vision package to prioritize your health and well-being.
• Additional recognition awards to celebrate your achievements.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level