QA Manager

MM Group•Clayton, NC

About The Position

The QA Manager will lead all Regulatory, Quality Control, and Quality Assurance activities at the site. This role serves as the final authority for quality product release decisions and acts as the primary quality liaison with external stakeholders. The position ensures customer quality requirements are met through a robust Quality Management System, drives continuous improvement, and manages the Site Quality team. A key aspect of this role is fostering a culture of quality and managing customer complaints and agreements.

Requirements

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.

Nice To Haves

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 development.

Responsibilities

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.