Senior Manager - Quality Assurance (Operations)

Hartalega; Sepang; On-site; MYR 120,000 - 150,000; Full time

Job summary

A manufacturing leader in Selangor seeks a Senior Manager - Quality Assurance to provide strategic oversight for quality systems across multiple plants. The ideal candidate will ensure compliance, drive performance improvement, and manage plant QA teams. This role requires a minimum of 10 years in quality assurance, strong knowledge of Good Manufacturing Practices, and experience in a managerial capacity. Competitive compensation and an opportunity to lead QA functions on a large scale are offered.

Qualifications

• Minimum 10 years of experience in quality assurance management in a manufacturing environment.
• At least 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.
• Ensure effective execution of QA strategies and continuous improvement.
• Guide and monitor QA performance with KPIs.

Skills

Good Manufacturing Practices (GMP)

Good Laboratory Practice (GLP)

Quality Management Systems

Root Cause Analysis (RCA)

Lean manufacturing concepts

Education

Bachelor’s Degree and/or Master's in Science (Chemistry), Engineering or equivalent

Job description

Senior Manager - Quality Assurance (Operations)

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.

DUTIES AND RESPONSIBILITIES

Business / Operations

Provide strategic oversight for QA operations, ensuring standard implementation of effective quality systems procedures and standards.

Guide and monitor QA performance using KPIs across assigned plants and ensure alignment with corporate goals, regulations, and customer expectations; and drive systemic improvements based on trend statistical analysis.

Ensure consistent execution of QA processes such as incoming materials inspections, in-process inspection, final product inspections, validation qualification and analytical laboratory testing.

Provide oversight and support to plant QA teams in managing supplier-related quality issues, including incoming rejections, material holds, and effective SCARs.

Review and analyse supplier quality trends across all plants; accelerate systemic issues to Procurement and Central QA as needed.

Provide technical support to Plant QA Managers in troubleshooting, root cause analysis, corrective actions and process improvement related to laboratory testing failures or findings.

Oversee implementation of validation and qualification protocols and ensure alignment across plants.

Supporting change control processes including changes related to supplier, FMEA, and risk management activities across all plants under supervision.

Ensure effective implementation and tracking of CAPA, complaint handling and audit readiness at each plant.

Review and approve formal response to customers regarding complaint resolution and product related actions.

Track complaints across plants and look for recurring issues to identify system issues.

Standardize quality related documentation and audit practices across the plants to ensure consistency and compliance.

Lead multi-plant readiness for external and internal audits, support audit responses and closure activities.

Coordinate with central QA for procedural updates, compliance issues, and harmonization initiatives.

Facilitate regular communication between plants. Coordinating best practices and providing guidance on operational challenges.

Monitor resource usage and quality related costs to support efficient operations across plants.

Manage performance appraisals, development plan, and succession planning for subordinates.

Any other duties or tasks as assigned by your superior.

People / Stakeholder Management

Lead, guide and coach Plant QA Managers to ensure strong leadership and operational QA performance at each plant.

Build and develop QA talent pipeline across all assigned plants, including training and succession planning.

Promote inter-plants collaboration, knowledge transfer, and best practice deployment.

Act as a bridge between Central QA and plant-level execution to ensure seamless communication and execution.

Build strong cross-functional partnership with Operations, Engineering, Supply Chain, and Central QA functions to support quality goals.

Foster a proactive and accountable quality culture across all supported plants.

REQUIREMENTS

Education: Bachelor’s Degree and / or Master in Science (Chemistry), Engineering or equivalent.

Work Experience: Minimum 10 years experienced in quality assurance management similar capacity preferably in manufacturing industry, with 4 years in a managerial post.

Technical and Professional Knowledge: Good Manufacturing Practices (GMP) and 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 and manpower planning.