Senior Specialist, Global External Quality

The responsibilities also include the evaluation of the general performance of contractors and the identification, negotiation, implementation and follow-up of process and systems improvements, as well as the organization and conduct of quality management review with contract manufacturing organizations:

• Management of deviations, complaints & CAPA by ensuring the tracking, timely and appropriate investigation, documentation of impact assessment, close out with involvement of partners and contractors
• Provide quality support for the manufacture of products at Contract Manufacturer Organizations (CMOs) that are located either in Europe.
• Collect and perform trend analysis based on indicators as well as feedback from other departments
• coordinate the preparation of CMO’s and internal departments regulatory inspections, as well as attend on site as needed or on call
• Perform risk assessments as preventive measures or in response to product/quality system failures, investigations and regulatory observations
• Perform quality review and approval for change requests with impact to contract manufacturing or related supply chain operations
• Work in cross-functional teams for the transfer or set-up of drug product processes at the (risk assessment, validation protocol and report review and approval, defining and following up on quality topics and performance indicators)
• Review and approve regulatory files prior to submission, for area of competence
• Participate to the preparation of annual product quality reviews
• Participate to Asset / Virtual Plant Team meetings for products and area of competence

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• At least 5 years of experience in similar position in pharmaceutical or biotechnology industries
• Proven experience in either manufacturing, development, quality or regulatory and knowledge of medical/biological products
• Strong understanding of cGX

In this position, you are responsible for managing the Quality interface with manufacturing and testing partners for commercial & clinical large molecules (parenteral) drug products by ensuring quality of product, process transfers, validations, investigations, tracking and resolution of issues in a timely manner as well as process improvements.