About the job
Join Sobi’s mission to enhance the lives of individuals living with rare diseases through the assurance of the highest product quality and patient safety standards.
As an External Quality Operations Manager (EQOM), you will play a crucial role in managing the quality performance of our external manufacturing partners. Serving as the primary liaison for these suppliers, you will ensure that each batch produced complies with GMP/GDP standards, adheres to Quality Technical Agreements, and meets Sobi’s global quality benchmarks.
Your position will act as a vital link between Sobi and its external network, fostering compliance, collaboration, and ongoing enhancements to sustain a reliable product supply while supporting Sobi’s expanding global reach.
This role provides the unique chance to collaborate across multiple functions including Manufacturing, Supply Chain, Technical Operations, and Regulatory Affairs, fortifying Sobi’s dedication to delivering high-quality medications to patients globally.
Key Responsibilities:
- Act as the EQOM, serving as the single point of contact for all quality-related activities at the Contract Manufacturing Organization (CMO).
- Ensure compliance in all handling, manufacturing, and distribution aspects with Sobi’s Quality system and applicable CGMP regulations through effective Quality Technical Agreements (QTA).
- Support the release of products to markets.
- Assist in the qualification of external service providers (CMOs).
- Establish and maintain appropriate Quality Technical Agreements (QTA) that clearly define roles and responsibilities between Sobi and external suppliers.
- Implement and monitor Quality Risk Assessment and KPIs for external quality activities, guiding the development and monitoring of remediation plans to address issues effectively.
- Ensure that CMOs provide product reviews or data (APQR/PQRs, stability reports) as specified in the QTA, evaluating product and process performance against Sobi’s requirements.
- Manage and approve quality issues, including deviations, CAPA, and complaints, in accordance with QTA and Sobi standards.
- Oversee change requests from both the CMO and Sobi in alignment with the QTA.