Quality System and Compliance Manager

Job Description

Job Description

The Quality System and Compliance Manager is responsible for overseeing quality and compliance activities for Langham Logistics supporting the pharmaceutical industry, including biologics, vaccines, and general pharmaceutical products. This role ensures all operations meet regulatory requirements, client expectations, and company standards while maintaining a state of audit readiness.

The Manager will implement, maintain, and continuously improve the Quality Management System (QMS), with a strong focus on cGMP, GDP, and cold chain requirements for sensitive pharmaceutical products.

Key Outcomes Expected

• Develop, implement, and maintain a compliant Quality Management System (QMS) in accordance with cGMP, GDP, FDA, and ICH guidelines.
• Oversee document control, change management, deviation handling, CAPA, and training programs.
• Conduct and manage internal audits, coordinate client audits, and support regulatory inspections.
• Ensure compliance for all pharmaceutical storage, handling, and distribution activities, including cold chain logistics for biologics and vaccines.
• Monitor and ensure the integrity of temperature-controlled shipments, including validation of storage and transportation equipment.
• Review and Approve investigations, deviations, nonconformances, and customer complaints; root cause analysis and corrective actions.
• Maintain quality metrics and prepare management review reports to monitor system performance.
• Collaborate with operations, warehouse, and client service teams to ensure adherence to GDP and cold chain protocols.
• Review and approve SOPs, validation protocols, and quality agreements.
• Ensure all associates receive appropriate quality and compliance training.
• Support continuous improvement initiatives to drive operational excellence and regulatory compliance.

Education and Experience

Preferred Skills :

Physical Demands

Work Environment

This role operates in a regulated warehouse and office environment, including areas requiring temperature-controlled storage. Occasional travel may be required for audits, training, or client visits.

Disclaimer

This job description is not intended to be all-inclusive. This position may be required to perform other related duties assigned to meet the ongoing needs of the organization. Langham reserves the right to modify job responsibilities and expectations as business demands evolve.

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