Quality & Regulatory Lead, Indonesia

IDN - 2710 PT Takeda Life Sciences; Pluit; On-site; IDR 90,000,000 - 150,000,000; Full time

Job summary

Takeda BioLife Indonesia seeks a Quality & Regulatory Manager to establish and maintain the quality and regulatory framework for plasma operations in Indonesia, under the BioLife brand.

The role drives QMS development, regulatory licensing, inspection readiness, and training across BioLife centers, ensuring GxP compliance with BPOM and Takeda standards while fostering a culture of integrity and continuous improvement.

Qualifications

• Minimum 5–10 years in QA and/or Regulatory Affairs in pharma, biologics, or plasma
• Experience with GxP systems, inspections, and BPOM familiarity
• Proven ability to lead cross-functional teams and global/regional QA/RA initiatives

Responsibilities

• Establish and maintain QMS in Indonesia aligned with global BioLife/Takeda standards
• Lead regulatory licensing, submissions, and interactions with BPOM and health authorities
• Ensure ongoing site licensing and compliance with local laws
• Oversee inspection readiness, audits, CAPA, deviation management, and change control
• Develop and deliver QA/RA training for local teams
• Maintain document control, data integrity, and reporting of KPIs
• Coach Quality Representatives across BioLife centers in Indonesia
• Collaborate with Operations, Medical Affairs, HR, and EHS to embed quality in daily ops
• Support site expansion projects and process improvements

Skills

Quality leadership

Regulatory expertise

Analytical thinking

Communication

Collaboration

Attention to detail

Project management

Integrity & ethics

Bahasa Indonesia & English

Education

Bachelor’s or Master’s in Life Sciences/Pharmacy

Job description

Takeda BioLife Indonesia seeks a Quality & Regulatory Manager to establish and maintain the quality and regulatory framework for plasma operations in Indonesia, under the BioLife brand.

The role drives QMS development, regulatory licensing, inspection readiness, and training across BioLife centers, ensuring GxP compliance with BPOM and Takeda standards while fostering a culture of integrity and continuous improvement.