External Quality Operation Manager

Company DescriptionSobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere. Job DescriptionThe External External Operation Manager (EQOM)is responsible for a wide range of activities/tasks related to the Quality oversight of external suppliers in charge of the manufacturing activities for a product.

Acting as a single point of contact with the external supplier, the External Quality Operation Manager has a key role to ensure compliance of the external supplier with current GMP & GDP regulations, the Quality Technical Agreement and with Sobi procedures and policies to enhance the product supply of medicines to consumers and to support the fast growth of Sobi. This role is also responsible for managing the quality interface and cross-functional relationships with Sobi stakeholders.

Key Responsibilities/Scope Of The JobPerform 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 Techincal Agreement, that they meet relevant CGMP regulatory requirement.

Support the release products by QP Delegate according to delegation documents, when necessarySupport the External Service Provider (CMO) QualificationEnsure Quality Technical Agreement (QTA) be established appropriately and ensure valid QTA clearly defines roles & responsibilities between Sobi and the External SupplierEnsure 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 performanceEnsure 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 requirementManage/approve quality issues (deviations, CAPA and complaints) as per QTA and Sobi requirementEnsure that Change requests either from CMO or from Sobi are managed according to the QTA and Sobi requirementsSupport that Quality Audits of the CMO is performed according to Sobi requirement and the QTALead to define strategy of implementation and monitoring of key Quality transformation initiatives and align with all process stakeholders outside of Quality organizationLead or act as Quality representative in project related to CMO eg Tech Transfer, LaunchAssess and ensure CMO for Health Authorities (HAs) inspection readinessSupport HA inspections/audits of SobiResponsible to inform the line manager and cross functional teams of all critical & major issues and escalate any issues as per Sobi escalation policyEnsure a good collaboration is maintained within the Global Quality Operations and cross-functionallyEnsure the batch release as requiredQualificationsRequired:

High level education (university degree or similar) within relevant area such as pharmaceutical, biotech or life scienceMore 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 CMOsCurriculum is requested for evaluating the batch release qualification requirementDesiredMore than 2 years of working in global operation environment with English as a main languageProven experience of leading Quality KPI assessment and improvement at CMOsProven track record with FDA; EMEA or other Health AuthoritiesStrong understanding of risk assessment and risk management fundamentals / toolsFluently spoken and written EnglishPersonal AttributesIn order to be successful in this position you should have a in-depth understanding of the GMP & GDP requirements as well as the years of leading CMO quality oversight experience.

You are comfortable in a global and complex environment; have interpersonal and leadership skills with ability to influence CMOs in a cross-functional environment to foster decisions and to propose solutions. Furthermore, you have great collaborative skills to develop strong relationship within Sobi but also with CMOs. You are proficient with planning tools and highly organized to help you coordinate key deliverables within the team. You have the ability to coach and lead others to grow high performing teams.

Additional CommentsBeing flexible and agile, Open for change and adapting to the new ways of working for improving operational efficiency, proactive and ownership driven performance