China External Quality Lead - Authorized Qualified Person

Benefits

Additional Information

The scope of this position is to oversee the strategy and execution of Quality operations for Biogen commercial products manufactured at contract manufacturing organisations (CMOs) in China as well as Distribution of all Biogen product marketed in China. Act as Authorized Qualified Person Or Responsible Person (RP) for finished goods release/batch certification and importation, and issue product release reviewed records in China as per Drug Administration Law of the People's Republic of China (2019 Revision), Measures for the Supervision and Administration of Drug Production of China (2020 Issuance) and Measures for the Administration of Drug Registration of China (2020 Issuance). The Authorized Qualified Person should have the expected exposure, experience and working knowledge of regulatory authorities and should maintain effective working relationships with both the Shanghai Municipal Medical Products Administration and National Medical Products Administration (NMPA). The RP is responsible for ensuring that each individual batch has been manufactured in compliance with laws in force in China, in accordance with the requirements of the marketing authorization (MA) and with Good Manufacturing Practice (GMP). As Responsible Person, she / he is authorized to give directives (also towards management) in her / his area of responsibility. As Quality Head for the site, ensure the Quality Management System (QMS) provides the foundation to ensure Biogen consistently provides products that meet customer needs, applicable regulatory requirements and includes processes for continuous improvement. This leader is responsible for communicating quality issues to senior management, driving their resolution, influencing and negotiating with the External companies (CMOs, Partners) and leading cross functional teams such as Planning, Logistics, Sourcing, External Manufacturing, Manufacturing Sciences, Quality Control, Commercial Qualities, Regulatory Affairs, Patient Services and Safety and Risk Management. He / she reports to the Global Head of Quality Commercial Operations. This position manages the China Site Quality team and RP release delegates to ensure continuous supply of compliant Medicinal Products to China Accountable on API, drug products and Finished Medicinal Product release in China Responsible for product release (certification and importation) and to ensure that the production and testing of each batch of released products are in accordance with the related regulations, the registration requirements and specifications Prior to the release of each batch, the Qualified Person must issue a review record for product release according to the requirements in the above bullet and archive it to the batch record. Ensure that all starting materials, packaging materials, intermediate, bulk and finished products meet the registration requirements and specifications Ensure that the batch records are reviewed before product release Ensure that all necessary testing is carried out Ensure appropriate staff, training, and organization to perform efficient commercial & Clinical product release on time Influence the strategy of manufacturing Biogen products at the CMOs and to sustain without disruption of the supply chain Contribute to technology transfer or improvements projects through establishment of needed release process update Perform Key Process Indicator analyses including feedback from other departments (for example planning). Identify appropriate actions and ensure successful implementation Lead as Biogen China representative the Health Authority inspection on site Manage Stakeholder for the commercial release activities through SME assessment and decision making Quality System Identify and drive improvements/updates of the GMP/GDP/GSP documentation related to Quality System in use in China To participate in quality management activities such as establishment of the quality system, self-inspection, external quality audit, validation, adverse drug reaction reporting and product recalls Identify any compliance gap in Biogen processes and collaborate with appropriate stakeholders to fix the issue Support local Quality system (change control, deviations, CAPAs, ...) as required Ensure adherence to serialization and data integrity requirements Approve specifications, sampling instructions, testing methods and other quality management procedures Review and approve all quality related changes Ensure all significant deviations and out-of-specification results are timely investigated and handled Approve and monitor any contract analysis Check the maintenance of premises and equipment for the purpose of maintaining a sound operating state Ensure the necessary qualifications or validations are done appropriately, and to review and approve validation protocols and reports Ensure self-inspection is done Assess and approve material suppliers Ensure all quality related complaints are timely and properly investigated and handl

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