Quality Lead - Site Compliance & Audit Readiness

Johnson & Johnson Sdn. Bhd.; Selangor; On-site; MYR 180,000 - 240,000; Full time

Job summary

Johnson & Johnson Sdn. Bhd. in Malaysia is recruiting a CQ Lead, Malaysia, based in Petaling Jaya. You will manage the site quality system, oversee supplier and distributor quality, and ensure compliance with DS policies and local regulations.

The role covers handling adverse events, audits, change control, complaints, CAPA, product release, and documentation. You will lead cross-functional teams to sustain quality, drive continuous improvement, and support regulatory inspections.

Qualifications

• Requires knowledge and understanding of industry and regulatory standards.
• Experience in training, supervising and risk-based approach.
• Good interpersonal and communication skills.
• Ability to plan and manage inspection activities.
• Demonstrated ability to deliver results.

Responsibilities

• Oversee site quality management system activities including change control and supplier oversight.
• Ensure adverse event reporting to health authorities where required.
• Lead inspection management and audit readiness.
• Coordinate NC/CAPA management and trending metrics.
• Support product release, returns and related quality processes.

Skills

Quality systems

Regulatory knowledge

Audit readiness

Change management

Communication skills

Inspection management

CAPA

Job description

Johnson & Johnson Sdn. Bhd. in Malaysia is recruiting a CQ Lead, Malaysia, based in Petaling Jaya. You will manage the site quality system, oversee supplier and distributor quality, and ensure compliance with DS policies and local regulations.

The role covers handling adverse events, audits, change control, complaints, CAPA, product release, and documentation. You will lead cross-functional teams to sustain quality, drive continuous improvement, and support regulatory inspections.