Site Quality Lead

Site Quality Lead

Final date to receive applications: 14 August 2026

Department: Quality

Employment Type: Full Time

Location: Newburyport, MA

Compensation: $140,000 - $170,000 / year

The Site QA Lead is responsible for leading all Quality Assurance operations and implementing & maintaining the effectiveness of the site's Quality Management System (QMS). This role serves as the senior quality leader for the facility and provides strategic and tactical leadership to ensure compliance with customer, regulatory, and company requirements while driving a culture of continuous improvement. This position is accountable for quality systems, quality assurance, internal audits, external audits, corrective and preventive actions, change management, document control, investigations, training and regulatory compliance activities.

The Site QA Lead will lead the execution and sustainability of corrective actions resulting from recent system audits and establish a robust site internal audit program.

• Serve as the senior quality leader for the site and a member of the site leadership team.
• Develop, communicate, and execute the site's quality strategy and objectives.
• Promote a culture of quality, compliance, accountability, and continuous improvement throughout the organization.
• Partner effectively with Operations, Supply Chain, Commercial, R&D, Engineering, EH&S, and Corporate Quality functions.
• Execute resource management within the Quality Organization as needed

• Own and maintain the site's Quality Management System.
• Ensure compliance with applicable quality standards, customer requirements, and company procedures.
• Manage document control, training compliance, change management, deviations, nonconformances, CAPA, risk assessments, and management review processes.
• Establish metrics and dashboards to monitor QMS effectiveness and drive improvements.

• Lead all customer, regulatory, certification, and corporate quality audits.
• Own remediation and sustainability of corrective actions resulting from recent six-system audit findings.
• Develop and implement a site-wide internal audit program, including auditor qualification, audit scheduling, execution, reporting, and effectiveness verification.
• Ensure audit readiness across all departments and functions.

• Lead root cause investigations and corrective/preventive action programs.
• Ensure timely closure and effectiveness verification of quality actions.
• Drive continuous improvement initiatives focused on process performance, compliance, data integrity, and customer satisfaction.
• Utilize risk-based decision making and quality metrics to identify improvement opportunities.

• Manage daily Quality Assurance activities supporting manufacturing and product release.
• Provide oversight of batch record review, product disposition, change controls, deviations, and investigations, as applicable.
• Ensure quality requirements are integrated into manufacturing and support processes.
• Support introduction of new products and technology transfers while maintaining quality compliance.

• Lead, coach, and develop Quality personnel.
• Establish performance expectations and support ongoing employee development.
• Build organizational capability through training, mentoring, and succession planning.
• Foster cross-functional collaboration and quality ownership throughout the site.

• Serve as the primary site representative for customer quality matters.
• Manage customer complaints, responses, investigations, and quality questionnaires.
• Support customer visits and quality-related business development activities.
• Maintain productive relationships with regulatory agencies, certification bodies, and key customers.

• Champion safe work practices and ensure compliance with all applicable EH&S requirements.
• Support site initiatives that promote operational excellence and safe manufacturing practices.
• Participate as a member of the site leadership team in achieving overall business objectives.