Lowongan Kerja Jakarta Raya Posisi Clinical Operations Team Leader And Quality Manager di PT. Daewoong Pharmaceutical Indonesia

Info Loker

Perusahaan	PT. Daewoong Pharmaceutical Indonesia
Posisi	Clinical Operations Team Leader And Quality Manager
Tempat	Jakarta Raya
Jenis Pekerjaan	Full Time
Spesialisasi Dibutuhkan	Manajemen (Kesehatan & Medis)
Gaji Min	Rp. 2.000.000
Gaji Max	Rp. 8.500.000

Company Introduction

Established in 2022 in Cikarang, Daewoong Pharmaceutical Indonesia is leading the way in regenerative medicine. Built on Daewoong’s decades of expertise, we became the first Korean company in Indonesia to receive GMP certification for stem cell processing — a milestone that marks our dedication to quality and innovation. We produce high-quality umbilical cord and adipose-derived stem cells, and continue to expand our pipeline into NK immune cell and exosome therapies. As we grow, we’re also advancing cosmetics and chemical pharmaceuticals to widen our healthcare impact. Each step brings us closer to our goal: to improve lives by offering new hope to patients through cutting-edge science.

Company Culture

At Daewoong, we believe healthcare is more than medicine — it’s about creating better lives. Guided by our WIN-WIN-WIN philosophy, we grow together with our people, customers, and society. We value autonomy, encouraging our team to work in their own best way — where, when, and how they feel most focused. Growth is our priority: we set bold goals, learn continuously, and embrace feedback. Here, work isn’t just a job — it’s a chance to do something meaningful and impactful.

Why Join Us?

1. Top-Tier Salary: We offer a highly competitive salary that reflects your skills and experience in the wellness and beauty industry.

2. Performance-Based Compensation: Your hard work and results are directly rewarded with performance-based compensation, and opportunities for rapid promotions.

3. Autonomous and Immersive Work Culture: Work in an environment that promotes ownership, independence, and deep engagement.

4. Meaningful Work with Societal Impact: Your contribution helps drive a triple-win: employee growth, customer satisfaction, and societal advancement.

5. Expert Training & Knowledge: We are committed to your development. You’ll receive specialized training in partnership, including direct learning from Korean expertise.

6. Exclusive Korea Trips: Top performers will be rewarded with a unique trip to Korea, offering a chance to experience our roots and culture firsthand.

7. International Career Path: Exceptional talent will have the opportunity for overseas training or placement, paving the way for a truly global career.

Team Introduction

The Medical and Development Team at Daewoong Pharmaceutical Indonesia (DPI) is composed of 11 skilled professionals dedicated to advancing clinical research and regulatory excellence. The team collaborates closely with global headquarters, ensuring alignment with international standards and innovative trial execution. We value scientific integrity, compliance, and the continuous development of both our people and processes.

Job Responsibilities

Clinical Operations Team Leader

1. Trial Oversight: Lead planning, execution, and close-out of clinical studies across all phases.

2. Site Management: Select, qualify, and monitor clinical sites to ensure GCP compliance.

3. Cross-Functional Coordination: Collaborate with data management, regulatory affairs, pharmacovigilance, and biostatistics teams.

4. Timeline & Budget Control: Oversee project milestones, allocate resources, and manage budgets.

5. Risk Mitigation: Identify operational risks and implement corrective actions.

6. Team Leadership: Mentor Clinical Project Leads (CPLs) to drive performance and accountability.

7. Stakeholder Engagement: Maintain effective communication with sponsors, investigators, and internal leadership.

8. Protocol Adherence: Ensure trials comply with SOPs, ICH-GCP, and regulatory requirements.

Quality Management (QM) – SOPs

• SOP Governance: Define SOP templates, version control, approval workflows, and review schedules.

• Regulatory Alignment: Ensure SOPs meet ISO, ICH-GCP, and BPOM standards.

• Audit Readiness: Maintain SOP traceability to support inspections and audits.

• Change Control: Update SOPs based on regulatory changes, audit findings, and operational feedback.

• Training Oversight: Coordinate SOP-related training and track staff competency.

• Process Harmonization: Align SOPs across departments to improve compliance and consistency.

Job Specification

Required Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or Health Sciences

• Minimum 5–7 years of experience in clinical research or trial management

• Proven leadership in multi-site clinical trials and cross-functional coordination

• Solid knowledge of ICH-GCP, ISO standards, and local regulations (BPOM)

• GCP Certification

• Fluent in English; strong communication and stakeholder management skills

Required Skills & Competencies

• Clinical Trial Expertise: Protocol development, trial operations from start-up to close-out

• Project Management: Budget control, milestone tracking, resource planning

• Regulatory Compliance: Familiarity with inspection readiness and audit trails

• Risk Management: Identify operational risks and apply CAPA

• Leadership & Team Development: Coaching and mentoring capabilities

• Cross-functional Collaboration: Coordination with medical, regulatory, PV, and data teams

• Stakeholder Engagement: Sponsor and investigator relationship management

• Technology Proficiency: CTMS, EDC systems, data integrity assurance

• Strategic Thinking: Align operations with company and regulatory objectives

Preferred Qualifications

• Advanced degree (M.Sc., Pharm.D., or equivalent)

• Prior experience as Clinical Project Lead or Clinical Operations Manager

• Experience in SOP development or quality assurance in clinical settings

• Understanding of international submission requirements (FDA, EMA, etc.)

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