Job Details
We are currently looking for a QA Director for a leading player in the Chemical Manufacturing Industry for their expansion. This company has a legacy of more than 30 years in Malaysia. This position requires your urgent attention.
- Based in Selangor
- Reporting to: COO
Responsibilities
- Lead Quality Assurance strategy across plant and central functions, ensuring alignment with business objectives and regulatory expectations.
- Define and execute long-term quality improvement roadmaps, maintaining and strengthening enterprise QMS compliance (ISO 13485, FDA QSR, MDR).
- Standardize and govern core QA processes across all sites, including CAPA, change control, complaints, audits, validation, calibration, and laboratory operations.
- Drive QA performance management through KPIs, benchmarking, structured reviews, and sustained corrective and preventive actions.
- Direct regulatory inspection and key customer audit readiness, serving as the escalation point for critical quality issues, regulatory findings, and supplier non-conformances.
- Lead enterprise risk management and cross-functional root cause investigations to deliver robust, long-term preventive solutions for systemic quality issues.
- Oversee quality integration in NPI/NPD initiatives, QA budgeting, and resource planning to ensure effective execution and compliance.
- Develop QA leadership and talent through coaching, succession planning, and knowledge sharing, while fostering a strong quality culture and strategic partnerships with internal and external stakeholders.
Experience
- Bachelor’s or Master’s degree in Engineering, Science, or a related field, with a minimum of 15 years in manufacturing, including at least 8 years in managerial roles.
- Proven leadership in Quality Management Systems (QMS), regulatory compliance, customer interactions, cross-plant QA oversight, and regulatory inspection readiness.
- Strong knowledge of GMP and manufacturing technologies, with expertise in QMS standards including FDA QSR (21 CFR 820), ISO 13485, and ISO 9001.
Skills
No additional skills required
Qualification
No additional qualifications required
Education
Bachelor Degree