External Quality Operation Manager – GMP

🕒 il y a 3 mois

🌲 North Carolina – Distant

🌲 North Carolina – Remote

💵 $130 000 - $153 000 / an

⏰ Temps Plein

🟡 Intermédiaire

🟠 Senior

👔 Manager

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Sobi - Swedish Orphan Biovitrum AB (publ)

Site WebLinkedInTous les Emplois

1001 - 5000 employés

Fondée en 1991

🧬 Biotechnologie

💊 Pharmaceutique

⚕️ Assurance santé

Biotechnology • Pharmaceuticals • Healthcare Insurance

Sobi - Swedish Orphan Biovitrum AB (publ) est un leader mondial dans la fourniture de traitements innovants pour les personnes atteintes de maladies rares. Spécialisé dans les domaines thérapeutiques tels que l'hématologie et l'immunologie, Sobi s'engage à améliorer l'accès des patients aux médicaments pour des affections rares et débilitantes. Avec un solide pipeline de R&D, l'entreprise poursuit activement de nouvelles thérapies et collabore à l'échelle mondiale pour transformer les soins aux patients dans des domaines tels que l'hémophilie et la thrombocytopénie immune. Sobi s'engage également dans des programmes étendus de durabilité et d'aide humanitaire, démontrant un engagement ferme envers des soins centrés sur le patient et les contributions sociétales.

Description

• 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

🎯 Exigences

• 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

🏖️ Avantages

• Competitive compensation for your work • Generous time off policy • Opportunity to broaden your horizons by attending popular conferences • Emphasis on work/life balance • Collaborative and team-oriented environment