Dedicated Quality Compliance Group Leader

1. Operational Management of DQCT

• Manage and coordinate the daily operations of all DQCO Officers across shifts.

• Review all deviation reports, observation logs, and escalation notifications produced by officers.

• Ensure DQCT shift coverage is maintained across all production schedules.

• Conduct daily/weekly briefings with officers to review findings, escalations, and priorities.

Performance Management:

• Monitor individual officer performance against KPIs and compliance targets.

• Identify skill gaps and coordinate targeted training and development activities.

• Conduct regular one-to-one reviews and formal performance assessments.

2. Compliance Oversight & Escalation

• Review all critical deviation reports and ensure timely escalation to the Head of DQCT and relevant management.

• Participate in root cause analysis (RCA) for significant compliance findings.

• Review and monitor CAPA plans for DQCT-identified deviations and track implementation effectiveness.

• Approve final observation reports before submission to QA and management.

3. Inspection Readiness & Regulatory Support

• Ensure all DQCT records, observation forms, and reports are maintained in a continuously audit-ready state.

• Serve as the primary DQCT point of contact during internal and external regulatory inspections.

• Coordinate DQCT contributions to regulatory inspection preparation and response activities.

4. Reporting & Trend Analysis

• Review compliance trend reports, KPI dashboards, and management review inputs produced by the DQC-REA Officer.

• Present DQCT performance summaries to the Head of DQCT and site senior management.

• Identify systemic issues and drive targeted improvement initiatives across DQCT functions.

5. Cross-Functional Coordination

• Act as the primary operational interface between DQCT and site QA, QC, Production, Engineering, and Microbiology teams.

• Coordinate cross-functional investigations, CAPA implementation, and compliance improvement projects.

• Facilitate effective communication between DQCT officers and department heads.

Education

• Bachelor's

Yêu cầu công việc

Education

• Bachelor's degree in Pharmacy, Microbiology, Chemistry, Biotechnology, Chemical Engineering, or a related science discipline.

• Advanced degree or specialized GMP management qualification is preferred.

Work Experience

• Minimum 3 years of experience in a GMP-regulated pharmaceutical environment, with at least 1 years in a team leadership or management role.

• Proven experience managing compliance oversight teams in sterile or aseptic manufacturing is strongly preferred.

• Demonstrated experience managing regulatory inspections (FDA, EMA, WHO, or local authority).

Technical Knowledge

• Comprehensive knowledge of cGMP: 21 CFR Part 210/211, EU GMP, WHO GMP.

• Strong expertise in Data Integrity (ALCOA+), Contamination Control Strategy, aseptic processing, and Environmental Monitoring.

• Proficiency in LIMS and GMP electronic systems is preferred.

• Knowledge of ICH Q9 (Quality Risk Management) and RCA methodologies.

Skills

• Strong leadership, team management, and people development skills.

• Advanced analytical, report writing, and communication skills in Vietnamese and English.

• Proficient in Microsoft Office; Power BI / advanced Excel is an advantage.

• Audit management and inspection coordination skills.

Personal Attributes

• High integrity, independent judgment, unwavering under production schedule pressure.

• Strong organizational skills with ability to manage multiple priorities under pressure.

• Willing to work shift-based schedules including nights and weekends as required.

THÔNG TIN KHÁC:

Thử việc: 2 months of probation with full salary

Thời gian làm việc: 44 hours/week

Cơ hội huấn luyện: A2E skill training

Đồng nghiệp: Friendly, supportive

Ngày nghỉ:

- 15 working days: from full 1 year to less than 3 years;

- 16 working days: from full 3 years to less than 7 years;

- 22 working days: from full 7 years or more to less than 37 years.

Phúc lợi:

Japanese Health Insurance for Staffs over 2 years contribution

Company trip, Team building activities

Holiday events

Phụ cấp khác:

Company bus from HCMC to Factory

Parking fee

Meal allowance

Quyền lợi

• Chăm sóc sức khoẻ: Japanese Health Insurance for Staffs over 2 years contribution
• Nghỉ phép có lương: Allowance, Annual leave, bonus, Training...
• Hoạt động nhóm: Company trip, Team building activities Holiday events
• Xe đưa đón: Company bus from HCMC to Factory
• Khác: Parking fee Meal allowance