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Job Description
As External Quality Operation Manager (EQOM), you will play a central role in ensuring strong quality oversight of external manufacturing partners and supporting the reliable supply of high‑quality medicines. Acting as the main quality interface with Contract Manufacturing Organizations (CMOs), you will collaborate closely with internal stakeholders across Sobi in a fast‑moving, global environment. /You will help ensure compliance, strengthen partnerships and contribute to developing efficient, future‑ready ways of working.
This position is a Hybrid role, based in our Global Hub in Basel Switzerland or Headquarter in Stockholm, Sweden reporting directly to the Associate Director, External Quality Operations.
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, that they meet relevant CGMP regulatory requirement.
- Support the products release by acting as 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. 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 is 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 project related to CMO eg Tech Transfer, Launch
- Assess and ensure CMO readiness for Health Authorities (HAs) inspection
- Support HA inspections/audits of Sobi
- Responsible to inform the line manager and cross functional teams of all critical major issues and elevate any issues as per Sobi escalation policy
- Ensure a good collaboration is maintained within the Global Quality Operations and cross-functionally
Qualifications
You thrive in a dynamic, international environment where priorities evolve and collaboration is essential. You are proactive, flexible and comfortable taking ownership, with the ability to balance operational detail and a broader quality perspective. /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
- 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
Here at Sobi we live by our core values:
Our mission andpurposeget us excited to come to work every day, butthere are a few more reasons to join our team:
- Opportunities for professional growth
- Competitive compensation for your work
- Diversity and Inclusion
- A flexible workplace that supports work-life balance
About Sobi
Sobi is a global biopharma company unlocking the potential of breakthrough innovations, transforming everyday life for people living with rare diseases. /
Quality Manager – Operations Quality Assurance (m/w/d) in Basel Arbeitgeber: Sobi
Sobi ist ein hervorragender Arbeitgeber, der sich durch eine engagierte und inklusive Unternehmenskultur auszeichnet. Mit einem starken Fokus auf die Work-Life-Balance, wettbewerbsfähigen Vergütungen und vielfältigen Möglichkeiten zur beruflichen Weiterentwicklung bietet Sobi seinen Mitarbeitern die Chance, einen bedeutenden Beitrag zur Verbesserung des Lebens von Menschen mit seltenen Krankheiten zu leisten. Die Position des Product Managers für Stoffwechselerkrankungen in Deutschland ermöglicht es Ihnen, in einem dynamischen Team zu arbeiten, das innovative Therapien entwickelt und gleichzeitig die Bedürfnisse der Patienten in den Mittelpunkt stellt.
