Quality & Regulatory Lead

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

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

Accountabilities:

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.

Takeda is an equal opportunity employer.