Nick Qiu

Enable Compliance (EC) establishes, maintains and execute activities to reduce regulatory compliance risk and drive continuous inspection readiness to ensure Roche’s License-to-operate and delivery of high-quality products to our patients. The key responsibilities: ● Ensure delivery of EC outputs: Audits, Inspections and other EC work packages. ● Collaborate with stakeholders to identify network inspection and audit risks and develop strategies to mitigate those risks. ● Support the EC Chapter to develop and maintain the goals, objectives, and strategic partnerships for Inspection Management and Audits at Roche sites/ affiliates, Contract Organisations, Partners, and Suppliers. ● Provide expertise in the interpretation and communication of emerging regulatory trends and regulatory intelligence impacting site GMP compliance . ● Contribute to optimize Operating model, and continually identify organizational efficiencies. ● Partner with leaders and team members to identify and implement compliance focused continuous improvement efforts to accelerate decision-making and drive efficiencies. ● Support capability development within EC to ensure appropriate flow to work. Key Achievements: - Successful PAI (inspection management and translation) - Due diligence audit for high value assets acquisition - Capacity calculation for department

Part of the Global Safety, Quality & Regulatory Compliance (SQRC) team that provide quality oversight on Manufacturing sites, Regulatory, R&D centers, Distribution centers and Commercial office to ensure compliance against RB policies and standards. Responsibilities: • Lead and manage audits in ASEAN region (Singapore, Malaysia, Indonesia, Philippines, Thailand, Vietnam, Japan and Korea). This includes senior stakeholder management and discussion with Country General Manager, Supply, Regulatory and Medical on product quality matters. • Conduct risk assessment for RB business units in ASEAN region to determine business performance and annual audit plan. This is then used to calculate the financial budget for the team/region. • Working with quality, supply and commercial to drive improvement in the region such as coaching, inspection readiness and quality workshops.

Lead and deliver different audits in alignment with the Audit Process providing a holistic view of risk management in Product Quality (GMP), Supply Chain (Crisis and Business Continuity Management) and Environment, Health and Safety (EHS). By reviewing the internal control framework, audits not only identifying gaps in control and risk management, but also good practices and insights to be shared and leveraged more broadly across GSK. Role includes senior stakeholder management to ensure audit/ CAPA agreement to drive business improvement. Audit experience: Program Audits: Review of global initiatives to help identify risks prior to implementation of processes and systems, which provides an advantage to GSK and business as there is still time to address control gaps and mitigate risk. • Globally launched Software – Global implementation of Software on artwork management. Theme Audits: Review the management of enterprise risk/risks within a specific business area, for a specific business activity/process, or across multiple entities/business areas. This provide assurance on how well the activity/process is implemented across a region. • Europe Product Compliant – review of product complaint process across 5 markets in Europe Entity Audits: Review the management of enterprise risk/risks for a specific entity (e.g. site or local operating company). This provides a maturity readout of the internal control framework for the site/LOC/Department. Examples include: • Manufacturing Site review - site remediation. Country experiences include U.K, US, Europe, India, China, Sri Lanka, Singapore, Asia Pacific.

Provide Microbiology technical support and manage day to day quality operation for eight manufacturing sites (5 - API, 1- Tablet, 1 - Dry Powder Inhaler, 1 - Tablet/Liquid Nasal spray) in Singapore. Mentor and supervise a team of Microbiologist/Analysts (8 direct reports), coordinate microbiological testing and urgent resource needs on a day to day basis. • Provide Microbiology SME/technical support for different dosage forms manufactured in Singapore. • Drafting of Risk/ Impact Assessment from Microbiology/ Quality point of view to support site improvement process (e.g., energy savings, test reduction and process improvement). • Assign and conduct investigations for microbiological related Out of Specifications results, trouble shooting activities for utility systems and clean rooms. This includes identification of risk and proposing corrective actions. • Co-ordinate with the head of department in performing appraisal of direct reports, department budget and KPI.

Startup team for Vela Operation Singapore Manage the Quality Control team (3 Direct reports) to ensuring Quality Control activities comply with Quality system, international standards and standard operating procedures. • Drafted Production Process validation protocols for product transfer, setup the ERP workflow (QAD), Plan and executed the qualification of cleanroom/manufacturing facility. • Track supplier performance; establish supplier audit program, site audits and supplier qualification. • Conduct/lead out of specification (OOS) investigations; carry out Correct and Preventive Action (CAPA) and Non-Conformance Report (NCR) activities. • Monitor quality indicators, review batch records, raw data and laboratory analysis. • Manage quality control operations to drive compliance and quality at the source. • Ensure timely process and product release testing support for manufacturing and assay qualification/validation. • Ensure Laboratory compliance with cGMP regulations and procedures. • Approve and authorize specifications, sample instructions, methods, and other Quality Control procedures, including changes. • Collaborate with cross function team (e.g. Production, R&D, Supply Chain and Procurement) on product transfer projects. • Manage and mentor a team of QC specialists. Supervise team members on all laboratory testing and routine monitoring activities. • Control departmental budgets for capital expenditure, operating expenditure and personnel head count. Develop clear job expectations, goals and objectives as well as performance review of direct reports. Achievement : • Successful ISO 13485 certification for Vela Manufacturing Facility

Previously Schering- Plough Sterile Biotech Facility (2011 - 2012) - Area owner for Environment Monitoring - Responsible for Deviation and CAPA write up - Monitoring for Grade A/B/C and Mediafill - Lead continous improvement projects that result in savings over $50,000 - Write up of position papers to justify sampling point reduction - Certified in MSD Lean six sigma Yellow belt API / Tablet Facility (2006 - 2011) - Support Cleaning Validation and Process Validations - Equipment IOPQ ( Autoclave, Incubator, MAS100 etc) - Purified water monitoring, Environment Monitoring - Product Testing (MLT), Growth Promotion Test (GPT)

- Primer Design - Gene Cloning - Journal Publication