Associate Manager - Quality & Compliance, Digital Systems

About the role

Roche is looking for an Associate Manager for its Quality and Compliance function, focused on digital systems, based in Shanghai. The role supports the mobilisation of new sites from a quality and compliance perspective and leads or supports the local implementation of global quality computerised projects such as ASPIRE.

Key responsibilities

• Lead or support the local implementation of global quality computerised projects (e.g. ASPIRE), covering master data readiness, end-to-end scenario test preparation and execution, SOP establishment and revision, end-user knowledge sharing and hypercare incident troubleshooting.
• Lead the master data maintenance role on the quality computerised system, including master data management, timely issue resolution, maintenance of S/4 and BRH system execution procedures and BCP.
• Identify, assess and escalate computerised system quality module risks, develop mitigation strategies and act as key contact providing technical and process support to cross-functional partners.
• Resolve system issues, remove technical barriers and provide ongoing operational and maintenance support after go-live.
• Assess the business suitability of system processes, gather user feedback and lead process improvements and continuous improvement initiatives.
• Perform other duties assigned by the line manager.

Required profile

• Degree in pharmaceutical sciences, life sciences, biology, biotechnology, chemistry, chemical engineering or a related discipline.
• Minimum 4 years of experience in pharmaceutical or biotechnology in quality assurance, GMP compliance, operations or validation, ideally in a multinational company.
• Experience with regulatory inspections by health authorities and representing the company before them.
• Aseptic filling experience expected.

Required skills

• Knowledge of EU GxP and quality system requirements for pharmaceutical and biotech manufacturing.
• Hands-on experience with SAP and Veeva.
• Understanding of cGMP and ICH guidelines, and exposure to the international network.
• Strong stakeholder management, problem-solving, critical thinking and agile skills; fluent English.