External Quality Operation Manager (GMP)

About the role

Join Sobi’s mission to improve the lives of people with rare diseases by ensuring the highest standards of product quality and patient safety.

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

Qualifications

• 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
• 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