Role Overview :
As the Business Process Owner for the site's GMP Training System, you will lead the design, implementation, and continuous improvement of a robust educational framework. Your mission is to bridge the gap between complex regulatory requirements (US 21 CFR, EU GMP, PIC/S) and daily operational excellence.
This is a Subject Matter Expert (SME) role that balances high-level strategy, such as developing site-wide training plans and managing digital platforms like MasterControl with hands-on quality management, including participating in health authority inspections and investigating training-related deviations.
Location : Tuas Biomedical Park, with shuttle bus provided islandwide
Responsibilities:
- Responsible for the site's GMP Training System.
- Lead the development and maintenance of strategic frameworks for industry-standard GMP training systems to drive site personnel's training compliance.
- Establish and continuously improve the site's GMP Training Management procedures to ensure compliance with cGMP, international regulatory and WuXi Biologics requirements.
- Lead and advise the site's GMP functions in developing (and subsequently deploying) structured, effective training plans for their respective personnel.
- As business process owner, maintain computerized training management systems (e.g. MasterControl) and collaborate with counterparts from other WuXi Biologics sites to continually improve the computerized systems capability in meeting company requirements and user needs.
- Develop, plan and conduct annual GMP quality training and other related trainings to ensure site personnel's understanding of (updated) quality requirements and expectations from regulators and WuXi Biologics clients.
- Oversee and track training compliance performance of the site's GMP personnel and periodically issue summary reports to site leadership and other key stakeholders.
- Partake in training-related change controls and deviation investigations, to support their effective closure.
- Participate in external client audits and health authority inspections as SME for site training program and training management topics.
- Perform any other tasks assigned by direct supervisor.
Requirements:
- Bachelor's degree or higher in Pharmacy, Microbiology, Biotechnology, Biomedical Medicine, or a related scientific discipline.
- Min. 6 years of proven professional experience in pharmaceutical production or quality management with specific expertise in training & knowledge management.
- In-depth knowledge of global regulatory standards, including US 21 CFR, EU GMP, and PIC/S GMP guidelines.
- Comprehensive understanding of pharmaceutical quality systems and learning / knowledge management concepts.
- Demonstrated ability to collaborate effectively in cross-functional team environments.
- Experience in people leadership or management is highly advantageous.
- Highly organized with the ability to plan, prioritize, and manage complex activities independently.
- Strong analytical and problem-solving skills, with the ability to troubleshoot and manage corrective actions.
- Committed to quality risk management and the continuous optimization of processes.
