QA Senior Manager [Chemical]

Randstad Malaysia; Kuala Selangor; On-site; MYR 120,000 - 160,000; Full time

Job summary

A leading player in the Chemical Manufacturing Industry is seeking a QA Senior Manager to provide strategic leadership for QA operations across all plants in Kuala Selangor. This role involves overseeing QA processes, managing supplier performance, and enhancing team capabilities. The ideal candidate should possess over 10 years of quality assurance experience in manufacturing, including at least 4 years in managerial positions, and have a strong knowledge of GMP, GLP, FDA QSR, and ISO standards. This position plays a critical role in ensuring compliance and optimizing operational efficiency.

Qualifications

• Over 10 years of quality assurance experience in manufacturing, including at least 4 years in managerial positions.
• In-depth knowledge of FDA QSR (21 CFR 820), ISO 13485, and ISO 9001.

Responsibilities

• Provide strategic leadership for QA operations across all plants.
• Lead and mentor Plant QA Managers to strengthen QA capabilities.
• Oversee comprehensive QA processes including inspections and validation.
• Manage supplier quality performance and mitigate risks.
• Drive multi-plant audit readiness and ensure compliance.
• Develop QA talent and promote a proactive quality culture.

Skills

Strategic leadership for QA operations

Mentoring and coaching

Knowledge of GMP and GLP

Root Cause Analysis (RCA)

Education

Bachelor’s or Master’s degree in Science (Chemistry) or Engineering

Job description

We are currently looking for a QA Senior Manager 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

• Provide strategic leadership for QA operations, ensuring consistent implementation of quality systems and procedures across all plants.
• Lead, mentor, and coach Plant QA Managers, leveraging KPIs, trend analysis, and performance evaluations to strengthen QA capabilities and drive results.
• Oversee comprehensive QA processes, including inspections (incoming, in-process, final), validation, lab testing, CAPA, complaint management, and audit readiness.
• Manage supplier quality performance, including rejections, holds, SCARs, trend monitoring, escalation of systemic issues, and oversight of change controls, FMEA, and risk mitigation.
• Deliver technical guidance for troubleshooting, Root Cause Analysis (RCA), corrective actions, and laboratory challenges to ensure consistent resolution across sites.
• Drive multi-plant audit readiness, standardize QA documentation and audit practices, and coordinate with Central QA to ensure compliance and operational alignment.
• Develop QA talent through coaching, succession planning, knowledge sharing, and deployment of best practices to enhance team capabilities.
• Promote a proactive, accountable quality culture by fostering cross-functional collaboration with Operations, Engineering, Supply Chain, and Central QA, while optimizing QA resources and operational efficiency.

Qualifications

• Bachelor’s or Master’s degree in Science (Chemistry), Engineering, or a related discipline.
• Over 10 years of quality assurance experience in manufacturing, including at least 4 years in managerial positions.
• In-depth knowledge of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and medical device Quality Management Systems, including FDA QSR (21 CFR 820), ISO 13485, and ISO 9001.