Quality Compliance Manager (Pharmaceuticals)

Summary:

• Work life balance
• Career Progression
• Attractive Package

Job Scope:

1. Develop and implement the factory’s quality strategy and objectives, ensuring a strong culture of compliance and safety across the entire organization.
2. Serve as the primary point of contact and official representative during inspections by regulatory bodies such as PIC/S, USFDA, and ASEAN.
3. Act as the custodian for the Quality Management System (QMS), overseeing change management, deviations, CAPA governance, and the supplier quality program.
4. Hold the final authority for product batch releases and maintain independent quality oversight to ensure all manufacturing meets safety standards.
5. Establish risk management frameworks (ICH Q9) and provide expert oversight on validation processes, including IQ, OQ, PQ, and cleaning validation.
6. Lead the QA and QC functions, managing department budgets, manpower planning, and the professional development of the quality team.
7. Apply deep knowledge of GMP (Good Manufacturing Practice) and international regulatory frameworks within a pharmaceutical manufacturing environment.
8. Communicate effectively with senior leadership and cross-functional teams to report on compliance KPIs and drive continuous improvement investments.

Job Requirements:

1. Possess a degree or diploma in Pharmacy, Life Science, Applied Chemistry, or a related technical discipline from a recognized institution.
2. At least 5 years of experience in Quality Assurance within a pharmaceutical manufacturing environment, including a minimum of 2 years in a leadership or managerial role.
3. Proven expertise in PIC/S GMP, USFDA, and ICH frameworks, with hands-on experience in QMS governance and the Validation lifecycle (including IQ, OQ, PQ, and Cleaning Validation).

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We regret that only shortlisted candidates will be notified.

Staffking Pte Ltd (20C0358) | Yuphine Lee | R22108749