Job location：Shanghai

Quality Partner responsibilities include, as applicable:
-Implement and maintain an effective and compliant Quality Management System in line with the Regional Quality strategy and according to UCB policies, corporate quality standards, global SOP’s, cGxP and applicable local regulation requirements.
-Ensure efficient information flow and effective communication of all relevant quality matters within the relevant Affiliate organization, from affiliate QA to the Global QA organization and vice-versa including but not limited to issue escalation and communication of new regulations via the Regulatory Intelligence Network (RIN).
-Represent the area on Regional quality meetings, Regional/Global Quality projects and improvement initiatives, as requested.
-Ensuring the execution of the local Quality Management System, end to end GDP duties and oversight on GDP and GMP activities of assigned areas (e.g. Importer management, importation and release).
o Management of complaints: conduct product complaint, quality inquiries, prepare Q&A; monthly reconciliation with drug safety and MI functions; PQC report training on new employees and partners; review and approve investigation report
o Deviation\CAPA\change control: ensure the quality aspects comply (contents, clarity completeness)
o Support and lead investigations (mainly focus on product complaint investigation and transportation deviation)
o Coordinate the periodic Management Review to assure consistency and compliance with UCB procedures and local regulations, and to ensure escalation to management of (potential) issues.
o Support the periodic Product Quality Review in accordance with the MAH responsibility.
o Support artwork/leaflet review and approval
o Support annual report preparation and submission
o Quality oversight to Local GxP Vendors in compliance with UCB Quality Standards and ENG guidance (qualification, quality agreements, vendor management, divestment). Approving any subcontracted activities impacting GDP or GMP at the affiliate.
o Establishing and adherence to self-inspection and external audit plans;
o Support execution of local recalls and all related correspondence with national competent authorities. Organize annual mock recall joint with UCB Zhuhai
-Actively engage in the Affiliate Risk to Value process, collaborate with key GxP and business stakeholders to identify and assess risks, and support the local risk champion in risk mitigation activities
-Ensure compliance to GDP and ensure proper shipping conditions are implemented for secondary and tertiary distribution, as applicable.
-Ensure readiness for MAH deputy or GSP inspections if needed
-Address any deficiencies identified through audits or other means by providing guidance for identification and timely implementation of appropriate corrective and preventive actions.
-Ensuring that a local DAL and GSP training program setup and its effectiveness checked.
-Ensuring all Quality deliverables are completed in a timely manner in accordance with Global SOPs (e.g. follow up and closure on all relevant complaints, deviations and CAPAs, change controls).
-Ensure information and documents are maintained in the UCB electronic system
-Ensure that the Intra-group quality agreement with Global QA and associated appendices are complete and up to date.
-Ensure appropriate systems in place at the Affiliate to ensure product traceability of all product
-Work with QA Management to contribute to other QA related work packages: new channel quality oversight, training per business needs.
-Support biosafety related event such as RA and Clinical Bio-IMP sample importation

Experience：
-Minimum of 5 years working in the pharmaceutical industry, in a quality management and/or Qualified Person position, having operational GDP (China GSP) and/or GMP experience.
-Cold chain product quality management would be an advantage
-Experience interacting with regulatory bodies or third-party organizations with respect to Quality systems and regulatory inspection preparedness would be an advantage.
-Staff Management would be an advantage.