Overview
Lead the end-to-end planning, execution, and delivery of the company's Digital Transformation for Quality Excellence project, ensuring the project meets quality, budget, and timeline objectives.
Responsibilities
- Partner with department heads (e.g., Production, Engineering, Supply Chain) to identify and scope future digitalization opportunities.
- Create a project pipeline that supports the factory's long-term strategic goals.
- Assemble and lead high-performing, cross-functional project teams comprising internal staff and external vendors/consultants.
- Oversee the overall budget for digitalization projects and manage the full lifecycle of vendor relationships, from selection and contract negotiation to performance management.
- Serve as the primary point of contact for digitalization initiatives.
- Provide clear, concise, and consistent progress reports to the Steering Committee and senior management.
Requirements
- Bachelor’s degree in Life Sciences, Information Technology, Engineering, or a related field.
- 10 years of professional experience with at least 5 years in a leadership role managing complex digital projects in a regulated environment.
- A proven track record of successfully delivering validated GxP systems (e.g., Quality Management Systems – QMS) within the pharmaceutical or biotechnology industry.
- Deep understanding of Good Manufacturing Practices (GxP) and Computer System Validation (CSV) principles.
- Experience with integrating Internet of Things (IoT) devices for real-time data acquisition in a manufacturing or GxP environment.
- A strong understanding of cybersecurity best practices.
- Experience with manufacturing execution systems (MES) or enterprise resource planning (ERP) systems is a strong advantage.
- Advanced program management skills, with the ability to manage multiple projects, control risks, and allocate resources effectively.
- Strong financial acumen with experience managing multi-million Euro project budgets.
- Fluent in English (both written and spoken).
- Willingness to be stationed in East Jakarta.
About the Company
PT Etana Biotechnologies Indonesia is an affiliate company focused on biosimilars. It is investing in building a biosimilar plant where a drug substance (host cell) and manufacturing process will be carried out locally.
Our portfolio includes a wide range of biosimilars in the fields of hormone products, and we look forward to involvement in the development of frontier biotech products. The company has an impressive track record of major scientific discoveries.