Quality Lead USA

We are looking for a hands-on and collaborative Quality Lead to oversee Quality execution across our U.S. operations.

In this role you will ensure that global Quality standards regional guidelines regulatory requirements and customer expectations are effectively implemented and maintained at the local level. You will work closely with Operations Warehouse Transportation Customer Service and regional and global Quality teams to support compliance audit readiness and continuous improvement.

This is an excellent opportunity for a professional who enjoys working in a fast-paced operational environment and wants to make a direct impact on quality performance and compliance culture.

Quality Operations and Compliance

• Serve as the local owner of Quality activities for the U.S. operation.
• Ensure compliance with applicable regulatory requirements customer expectations GDP GMP GxP standards and internal Quality policies.
• Support the implementation and ongoing maintenance of the local Quality Management System (QMS).
• Monitor operational processes to ensure consistency compliance and adherence to approved procedures.
• Manage and support SOPs CAPAs deviations change controls investigations and risk assessments.
• Identify and escalate significant compliance risks to regional or global Quality leadership.

Audits and Inspection Readiness

• Maintain continuous readiness for internal customer and regulatory audits and inspections.
• Coordinate and support audits inspections and customer Quality reviews.
• Track audit observations and ensure corrective and preventive actions are completed within established timelines.
• Provide documentation and evidence required during audits and inspections.

Documentation and Quality Systems

• Ensure Quality documents and records are accurate current controlled and compliant.
• Support document creation review approval and periodic review processes.
• Monitor employee training compliance and maintain appropriate training documentation.
• Ensure the traceability integrity and availability of Quality records.

Cross-Functional Collaboration

• Partner with Operations Warehouse Transportation Customer Service and other departments to maintain Quality compliance throughout operational workflows.
• Provide Quality support during the implementation of new customers services processes or operational changes.
• Serve as a trusted advisor on Quality-related operational decisions.
• Collaborate with regional and global Quality teams to ensure alignment with corporate standards.

Training and Quality Culture

• Promote a strong culture of Quality accountability and compliance throughout the organization.
• Coordinate and deliver local Quality training.
• Support Quality-related onboarding activities for new employees.
• Encourage operational discipline employee awareness and continuous improvement.

Continuous Improvement and Reporting

• Monitor Quality KPIs trends risks and recurring issues.
• Prepare reports that provide visibility into local Quality performance.
• Identify opportunities to improve processes reduce risk and strengthen compliance.
• Support corrective actions and process-standardization initiatives.

• Previous experience in Quality Assurance Quality Operations Compliance or a related role.
• Experience working within logistics transportation warehousing pharmaceutical healthcare clinical research or another regulated environment.
• Knowledge of Quality Management Systems and regulated standards such as GDP GMP or GxP.
• Experience supporting audits CAPAs deviations change controls investigations SOPs and risk assessments.
• Strong organizational documentation and problem-solving skills.
• Ability to work effectively with operational and corporate stakeholders.
• Strong communication skills and the confidence to identify communicate and escalate Quality risks.
• Detail-oriented proactive and comfortable working in a fast-paced environment.

This role offers the opportunity to take ownership of Quality activities within the U.S. operation while collaborating with regional and global teams. You will help strengthen compliance improve operational processes and promote a culture in which Quality is part of every decision.