SENIOR MANAGER - QUALITY ASSURANCE (PLANT)

Hartalega Holdings Berhad; Sepang; On-site; MYR 150,000 - 200,000; Full time

Job summary

A leading glove manufacturing company in Malaysia is seeking a Senior Manager for Quality Assurance. This role involves providing leadership across multiple plants, ensuring compliance with quality standards, and driving performance improvements. Candidates should have a Bachelor’s or Master’s degree in a relevant field, 10 years of experience in quality assurance, and strong understanding of regulatory requirements. The position offers competitive benefits and a clear career development path.

Qualifications

• 10 years experience in quality assurance management in manufacturing.
• 4 years in a managerial position.
• Knowledge of FDA QSR requirements and ISO standards.

Responsibilities

• Provide leadership and oversight of the QA function across multiple plants.
• Guide QA performance using KPIs to align with corporate goals.
• Oversee validation and qualification protocol implementation.

Skills

Good Manufacturing Practices (GMP)

Quality Management Systems

Lean manufacturing concepts

Root Cause Analysis (RCA)

Education

Bachelor’s Degree in Science or Engineering

Master’s Degree in Science (Chemistry)

Job description

SENIOR MANAGER - QUALITY ASSURANCE (PLANT)

Company Overview

Leading Growth Through Innovation

As the World's No.1 Nitrile Glove manufacturer, Hartalega is currently in the process of recruiting a diverse pool of talented people, across various specialisations and backgrounds. You will enjoy exceptional benefits and incentives, as well as a well-defined path for career success.

Hartalega is made up of a tight-knit, passionate and highly-skilled set of individuals. From our top executives, to our line technicians; we are all proud to be part of an elite group responsible for revolutionising the glove-making industry.

Job Description

OVERVIEW:

Provide leadership and oversight of the QA function across multiple plants. Responsible for standardizing effective quality systems, ensuring quality compliance, driving performance improvements, and supporting plant QA teams in achieving quality objectives. Ensure effective execution of QA strategy and continuous performance improvement across all plants.

Business / Operations

• Provide strategic oversight for QA operations, ensuring standardized implementation of quality procedures and systems.
• Guide and monitor QA performance using KPIs to align with corporate goals and drive improvements through trend analysis.
• Ensure consistent QA processes: incoming/in-process/final inspections, validation, and lab testing.
• Provide oversight and support to plant QA teams on supplier-related issues: rejections, holds, and SCARs.
• Review and analyse supplier quality trends; escalate systemic issues to Procurement and QA (Cental).
• Provide technical support in troubleshooting, RCA, corrective actions, and lab-related issues.
• Oversee validation and qualification protocol implementation; ensure cross-plant alignment.
• Support change controls including supplier changes, FMEA, and risk activities.
• Ensure implementation and tracking of CAPA, complaint handling, and audit readiness.
• Review and approve customer responses on complaints and product actions.
• Track plant complaints and identify recurring/systemic issues.
• Standardize QA documentation and audit practices to ensure compliance.
• Lead multi-plant audit readiness, support audit responses and closure.
• Coordinate with QA (Central) for updates, compliance, and harmonization.
• Facilitate plant communication and provide guidance on operational issues.
• Monitor QA-related costs and resource usage for operational efficiency.
• Manage performance appraisals, development plans, and succession for subordinates.
• Perform other duties as assigned by your superior

People / Stakeholder Management

• Lead, guide, and coach Plant QA Managers to strengthen leadership and QA performance.
• Build and develop QA talent pipeline through training and succession planning.
• Promote collaboration, knowledge transfer, and best practice deployment across plants.
• Act as a bridge betweenQA (Central)and plant execution for effective communication.
• Build cross-functional partnerships with Ops, Engineering, Supply Chain, and QA (Central).
• Foster a proactive, accountable quality culture across supported sites

REQUIREMENTS:

• Bachelor’s Degree and / or Master in Science (Chemistry), Engineering or equivalent.
• Minimum 10 years experienced in quality assurance management similar capacity preferably in manufacturing industry, with 4 years in a managerial post.
• Good Manufacturing Practices (GMP)& Good Laboratory Practice (GLP).
• Quality Management Systems related to Medical Devices i.e. FDA QSR requirements as per 21 CFR 820, ISO 2859 Sampling Procedures for Inspection, ISO 13485: QMS, ISO 14971: Risk Management Assessment and ISO 9001.
• Knowledge of Corrective Action and Preventive Action (CAPA) processes and Root Cause Analysis (RCA).
• Lean manufacturing concepts and operational excellence methods and practices.
• Work planning and scheduling; inclusive of operational & manpower planning.