QA Manager

What You Will Do

• Lead all Regulatory, Quality Control, and Quality Assurance activities at the site.
• Serve as the final authority for quality product release decisions for sale or supply.
• Act as the primary quality liaison with customers, regulatory agencies, certification bodies, and other external stakeholders.
• Ensure customer quality requirements and expectations are consistently met through a robust and audit-ready Quality Management System.
• Lead customer audit readiness activities, including preparation, hosting, evidence coordination, response management, CAPA commitments, and timely closure of findings.
• Drive continuous improvement by analyzing quality performance data, identifying trends, and implementing corrective and preventive actions.
• Manage and develop the Site Quality team, ensuring the effective execution of day-to-day quality functions.
• Maintain and continuously improve Quality Management Systems in alignment with company policies, industry standards, and customer requirements.
• Partner with the Site Leadership Team to foster a culture where quality is built into processes and operations.
• Manage customer complaints, ensuring timely investigations, root cause analysis, corrective actions, and closure in accordance with customer requirements.
• Serve as the primary contact for customer quality agreements and ensure customer-specific requirements are implemented throughout the site.
• Represent the site during customer audits, quality reviews, complaint escalations, and performance discussions.
• Oversee batch quality control testing and product release activities to support production schedules and customer commitments.
• Approve or reject raw materials, components, in-process materials, finished products, and labeling.
• Review production records and ensure deviations, errors, and non-conformances are thoroughly investigated and resolved.
• Lead Change Control, deviation investigations, root cause analyses, risk assessments, and CAPA activities.
• Manage calibration systems, ensuring schedules, records, investigations, and corrective actions remain current and effective.
• Oversee supplier qualification, supplier quality performance, audits, quality agreements, and supplier CAPA follow-up.
• Maintain the Electronic Quality Management System (eQMS) and ensure quality data remains accurate and up to date.
• Support compliance with GMP, ISO 9001, PS9000, FSC, BRCGS Packaging, customer requirements, and company policies.
• Approve quality procedures, specifications, standards, sampling plans, test methods, and quality-related process changes.
• Develop and maintain GMP and Quality Systems training programs.
• Promote data integrity, documentation control, and quality record management practices across the site.
• Lead, coach, and develop team members through mentoring, training, and performance management.

• Bachelor's degree in Science, Engineering, Quality, or a related discipline, or equivalent industry experience.
• Minimum of three years of experience in a Quality Management role within a manufacturing environment.
• Experience leading Quality Assurance, Quality Control, and Regulatory activities.
• Experience managing Quality Management Systems and driving continuous improvement initiatives.
• Experience conducting customer complaint investigations, root cause analyses, CAPA management, and corrective action implementation.
• Experience supporting product release, quality control, and manufacturing operations in a regulated environment.
• Experience preparing for, hosting, responding to, and closing customer, certification, regulatory, and internal audits.
• Experience managing supplier qualification programs, supplier audits, and supplier performance improvement initiatives.
• Experience developing and delivering GMP and Quality Systems training programs.
• Experience leading, coaching, and developing employees and cross-functional teams.
• Internal Auditor certification in applicable quality standards and management systems.
• Strong analytical, problem-solving, communication, and organizational skills.
• Ability to build effective relationships with customers, suppliers, auditors, and internal stakeholders.

• ISO 9001:2015 or BRCGS Packaging Lead Auditor Certification.
• Experience in the Printing and Packaging industry.
• Experience supporting Pharmaceutical and Healthcare customers.
• Experience preparing for, hosting, responding to, and successfully closing customer, certification, and regulatory audits.
• Demonstrated success improving quality performance, audit readiness, customer satisfaction, and CAPA effectiveness.
• Strong knowledge of GMP, quality systems, risk management, and regulatory compliance requirements.
• Six Sigma Green Belt certification.
• Experience leveraging quality metrics, dashboards, and data analytics to drive business improvements.
• Strong leadership presence with the ability to influence and engage stakeholders at all levels of the organization.
• Passion for building a culture of quality, continuous improvement, and employee…