Quality & Regulatory Lead

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Job Description:

The Quality & Regulatory Manager – Indonesia is responsible for establishing, implementing, and maintainingTakeda's quality and regulatory framework for plasma operations in Indonesia operating under the brand name BioLife.

Accountabilities :

• Quality Management System (QMS) Development & Oversight (≈25%)
• Establish and maintain BioLife's Quality Management System (QMS) in Indonesia in alignment with global BioLife and Takeda standards.
• Ensure compliance with GMP, GCP, GDP, and applicable Indonesian regulations governing plasma collection and biologics.
• Develop, review, and approve local SOPs, work instructions, and quality documentation.
• Oversee quality assurance processes, deviation management, CAPA implementation, and change control.
• Support center qualification, validation, and start-up activities to ensure readiness before launch.
• Regulatory Affairs & Licensing (≈20%)
• Serve as BioLife Indonesia's main liaison with national health authorities (e.g., BPOM, Ministry of Health).
• Lead the preparation, submission, and maintenance of regulatory documentation related to site licensing, inspections, and product or donor procedures.
• Ensure all BioLife plasma operation in Indonesia are licensed and compliant with local laws.
• Support registration activities for applicable regulatory submissions
• Monitor regulatory developments, interpret new or updated requirements, and communicate their impact to internal stakeholders.
• Support regulatory inspections and audits, ensuring prompt and accurate responses to authority requests.
• Inspection Readiness & Compliance (≈10%)
• Ensure continuous inspection readiness of all plasma centers and central support functions.
• Plan and coordinate internal and external audits; track and close all findings within agreed timelines.
• Maintain comprehensive audit trails and quality records for transparency and traceability.
• Quality & Regulatory Training (≈10%)
• Develop and deliver training programs to ensure all personnel understand and comply with relevant quality and regulatory requirements.
• Support qualification, requalification, and certification processes for local QA and operational teams.
• Promote a strong quality and compliance culture across BioLife Indonesia.
• Documentation, Data Integrity & Reporting (≈10%)
• Oversee document control, record retention, and archiving in compliance with Takeda's global documentation standards.
• Ensure data integrity, traceability, and accuracy across all quality and regulatory systems.
• Provide timely reports to regional QA/RA management, summarizing local KPIs, audit outcomes, and compliance trends.
• Quality Field Team Leadership & Capability Development (≈15%)
• Lead, coach, and develop the Quality Representatives across BioLife plasma centers in Indonesia.
• Provide day-to-day guidance and oversight to ensure consistent application of quality standards, procedures, and regulatory requirements.
• Build and sustain a high-performing quality field organization through effective performance management, talent development, and succession planning.
• Ensure Quality Representatives are appropriately trained, qualified, and equipped to support compliant plasma center operations.
• Foster a strong quality culture by promoting accountability, continuous improvement, and proactive identification and mitigation of quality risks.
• Facilitate knowledge sharing and standardization of best practices across all plasma centers.
• Cross-Functional Support & Collaboration (≈10%)
• Collaborate with Operations, Medical Affairs, HR, Engineering, and EHS to ensure quality and regulatory standards are integrated into daily operations.
• Contribute QA/RA expertise to expansion projects, new center setup, and process improvement initiatives.
• Support alignment with regional/global QA, RA, and PDT Regulatory Affairs to ensure unified compliance practices.
  
  

Education & Competencies (Technical and Behavioral):

• Bachelor's or Master's degree in Life Sciences, Pharmacy, Chemistry, Biotechnology, or related field.
  
  

Professional Experience

• Minimum 5–10 years of experience in Quality Assurance and/or Regulatory Affairs in the pharmaceutical, biologics, or plasma industry.
• Proven experience implementing and maintaining GxP-compliant Quality Systems.
• Experience preparing for and managing regulatory inspections and interactions.
• Familiarity with Indonesian regulatory frameworks and BPOM requirements strongly preferred.
• Prior experience in multinational or highly regulated healthcare environments advantageous.
  
  

Key Skills and Competencies

• Quality Leadership Expert in GxP compliance, deviation management, and continuous improvement.
• Regulatory Expertise Strong understanding of Indonesian and international regulatory environments.
• Analytical Thinking Skilled in risk assessment, root cause analysis, and corrective/preventive actions.
• Communication & Representation Effective communicator with authorities and cross-functional stakeholders.
• Collaboration Works across disciplines and geographies to ensure alignment and knowledge sharing.
• Attention to Detail Ensures accuracy and integrity in documentation and submissions.
• Project Management Manages multiple priorities, ensuring timely delivery and compliance.
• Integrity & Ethical Standards Acts with accountability, transparency, and alignment with Takeda values.
• Fluent in Bahasa Indonesia and English (both written and spoken).
• Willingness to travel extensively across Indonesia and occasionally within the region.
• During the initial phase, willingness to travel to the EU and/or US for onboarding, training, and familiarization with BioLife operations and quality systems.
• Open to occasional international travel to Takeda or BioLife headquarters (e.g., in the US, EU, or other global locations) for leadership meetings, summits, or strategic alignment sessions.
  
  

Locations:

Jakarta, Indonesia

Worker Type:

Employee

Worker Sub-Type:

Regular

Time Type:

Full time