• Ensure site validation governance by establishing and managing the site validation process, maintaining the site validation master plan, and overseeing the Global Validation Lifecycle Management System (GVLMS). Ensure compliance in site validation across facilities, utilities, equipment, systems, processes, analytical methods, and more.
• Manage manufacturing documentation, including the creation and maintenance of manufacturing master methods, batch records, electronic batch records (EBR), and master data in systems such as PAS-X.
• Lead product and process ownership initiatives, including critical process parameters (CPP), critical material attributes (CMA), critical quality attributes (CQA), and continued process verification (CPV).
• Direct new technical project deliverables according to plan, encompassing material source changes, technical transfers, new technology introductions, line expansions, and capacity uplifts.
• Act as a technical coach to enhance the capabilities of the process, manufacturing, and quality teams.
• Establish challenging individual objectives and development plans for subordinates, appraise department staff performance, and determine assignments and changes in employee status in accordance with company policy.
• Lead the team in problem-solving and technical investigations for complex issues, aiming to achieve process robustness and continuous improvement.
• Guide team members in mastering business risk analysis, problem-solving, opportunity identification, and team effectiveness.
• Collaborate with internal and external stakeholders, such as quality, supply chain, manufacturing, TOSI, Ops Regulatory, and China RA, to manage technical-related affairs.

Qualification and Capability

• A bachelor’s degree or higher.
• Professional expertise in pharmaceutical knowledge and experience, including production processes, validation, troubleshooting, investigation, and continuous improvement.
• Proficiency in both Oral Solid Dosage and aseptic process and microbiology knowledge.
• Professional expertise in process validation and cleaning validation.
• Strong statistical knowledge with experience in Design of Experiments (DoE) and limit setting.
• Experience in Project Management (PM) or Technical Support of Chemistry, Manufacturing, and Controls (CMC) variations and technical transfer (TT).
• Exceptional written and oral English communication skills.
• A minimum of 7 years' experience in pharmaceutical processes.
• Competence in risk management, critical analysis, and problem-solving.
• Strong leadership capabilities in communication, coordination, influence, judgement, coaching, and emotional intelligence.