Senior Manager - Quality Assurance (Operations)

Hartalega; Sepang; On-site; MYR 120,000 - 180,000; Full time

Job summary

A leading company in the healthcare manufacturing sector is seeking a QA Manager to oversee quality assurance operations across multiple plants. This role includes the implementation of effective quality systems and compliance with various quality standards. The successful candidate will need a strong background in quality management, excellent leadership skills, and significant experience in the manufacturing industry.

Qualifications

• Minimum 10 years experienced in quality assurance management, with 4 years in a managerial post.
• Knowledge of Quality Management Systems related to Medical Devices (FDA QSR, ISO 13485, etc.).
• Work planning and scheduling expertise required.

Responsibilities

• Provide strategic oversight for QA operations and ensure compliance with quality procedures.
• Guide and monitor QA performance using KPIs to drive improvements.
• Lead, guide, and coach Plant QA Managers to enhance performance.

Skills

Good Manufacturing Practices (GMP)

Good Laboratory Practice (GLP)

Corrective Action and Preventive Action (CAPA)

Root Cause Analysis (RCA)

Lean manufacturing concepts

Operational excellence methods

Education

Bachelor’s Degree and / or Master in Science (Chemistry)

Engineering or equivalent

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.

JOB DESCRIPTIONS

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 between QA (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.