Overview
Core Objective: Lead and manage the drug substance and drug product manufacturing teams to ensure efficient, compliant, and sustainable pharmaceutical production. This includes strict adherence to GMP regulations from the Asian Pacific and leading international regulatory agencies, as well as internal compliance protocols. The VP will ensure product quality and personnel safety, optimise production efficiency and cost, stabilise the supply chain, strengthen team development, implement EHS management, drive the adoption of new products, technologies, and equipment, and support the company’s strategic growth. The ultimate goal is high-quality, low-cost, on-time delivery.
Responsibilities
- Participate in and support the formulation and implementation of company development strategies and plans.
- Execute strategic plans and production schedules to make sure that manufacturing tasks are completed quickly.
- Develop annual production plans and departmental budgets in line with company goals.
- Coordinate cross-functional collaboration with Quality, CMC, HR, Finance, and Supply Chain departments.
- Reinforce and monitor quality and risk awareness among department staff per the company’s quality system; review production system performance and continuously improve staff capabilities.
- Ensure workshop safety and compliance with EHS standards; monitor production quality status and resolve issues through cross-departmental coordination.
- Organise and oversee the introduction of new products, technologies, and equipment into the production workshop.
- Support Quality in internal audits and inspections by NMPA, FDA, and partners; implement and report corrective actions.
- Guide, supervise, and review the completion of production tasks by subordinates; stay familiar with team performance and production data.
Requirements
- Solid knowledge of antibody and protein biologics manufacturing processes, with over 10 years of GMP-compliant commercial biologics production experience.
- At least 5 years of experience managing biologics manufacturing workshops.
- Hands-on experience in GMP facility operations, material management, and overall production operations.
- Strong communication, presentation, and leadership skills.
- Familiarity with GMP regulatory requirements in the biopharmaceutical sector.
- Proven ability to lead cross-functional teams to deliver strategic projects.
- Competence in managing departmental staffing and financial budgets.