Site Quality Lead — Regulatory & CAPA Excellence

Johnson & Johnson MedTech; Petaling Jaya; On-site; MYR 180,000 - 260,000; Full time

Job summary

Johnson & Johnson is recruiting a CQ Lead for Malaysia, located in Petaling Jaya. The role oversees the site quality management system, supplier and distributor quality oversight, and adherence to DS policies and local regulatory standards.

The position requires leading NC/CAPA, change control, audits, and product quality processes to ensure robust compliance and continuous improvement across the Malaysia site.

Qualifications

• Good interpersonal and communication skills.
• Analytical and problem-solving capabilities.
• Ability to prioritize and make decisions under pressure.
• Demonstrate change management and project management ability.
• Knowledge and application of quality and regulatory requirements.

Responsibilities

• Lead site quality management system activities to meet DS and local regulatory requirements.
• Oversee supplier/distributor quality oversight and related QC activities.
• Manage non-conformance, CAPA, and escalation processes with timely investigations.
• Coordinate pre- and post-audit activities; support inspections by regulators.
• Lead change control for site, ensuring timely records and impact assessments.
• Manage end-to-end complaint handling and customer communications.
• Ensure labeling, packaging, and documentation comply with internal procedures and local regulations.

Skills

Interpersonal skills

Analytical skills

Prioritization

Change management

Quality knowledge

Job description

Johnson & Johnson is recruiting a CQ Lead for Malaysia, located in Petaling Jaya. The role oversees the site quality management system, supplier and distributor quality oversight, and adherence to DS policies and local regulatory standards.

The position requires leading NC/CAPA, change control, audits, and product quality processes to ensure robust compliance and continuous improvement across the Malaysia site.