[Factory 1] Dedicated Quality Compliance Group Leader

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.