Quality Assurance (QMS & GMP Compliance) Supervisor

Role Purpose

Establish, operate, and continuously improve the Quality Management System to ensure GMP compliance, regulatory readiness, and quality culture across the organization.

Role Description

1. Quality Management System (QMS)

• Establish, implement, and maintain the Quality Management System (QMS) in compliance with GMP and regulatory requirements.
• Prepare, review, and manage SOPs, product specifications, batch records, and registration‑related documents.
• Oversee document control systems, ensuring proper lifecycle management, version control, and data integrity.
• Manage change control, deviation management, and CAPA systems, including investigation oversight and effectiveness checks.
• Ensure QMS processes are effectively implemented and continuously improved.

2. Training Management

• Develop and manage training plans and schedules to ensure GMP competency across departments.
• Oversee training record management, ensuring completeness, accuracy, and audit readiness.
• Monitor training effectiveness and compliance with internal and regulatory requirements.

3. Supplier Evaluation & External Quality

• Support and perform supplier evaluation and qualification activities.
• Review supplier quality documentation and support supplier audits when required.
• Ensure supplier quality performance aligns with company and regulatory expectations.

4. Compliance, Audit & Cross‑Functional Support

• Support internal and external audits, acting as QMS focal point when required.
• Collaborate with Production, QC, Engineering, RA, and other stakeholders to ensure effective QMS implementation.
• Support technology transfer activities from a quality system perspective.
• Support establishment and management of Contamination Control Strategy (CCS), where applicable.

Requirements

Required

• Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Biology, Biotechnology, Microbiology, Chemistry, Chemical Engineering, or related fields.
• Minimum 5 years of experience in QMS establishment and/or operation and GMP compliance within the pharmaceutical industry.
• Strong knowledge of GMP, documentation systems, and quality processes.
• Proficiency in English (written and spoken).

Preferred

• Experience in QA roles within the biopharmaceutical industry.
• Experience in initial setup and operation of QMS in a newly constructed biopharmaceutical facility.
• Experience in establishment and management of CCS (Contamination Control Strategy).
• Experience supporting technology transfer processes.
• Holder of Pharmacist License (STRA).

• Multinational Company Environment
• SK Management Work Culture
• Social Insurance Fully Paid by Company
• Private Insurance Fully Paid by Company
• Lunch box & Snack box
• Employee Shuttle bus
• Annual Bonus based on Performance