GMP Quality Assurance Auditor

Job Title: GMP Quality Assurance Auditor (fully onsite) Job Description The Quality Assurance Auditor develops and maintains a robust internal compliance program that ensures adherence to applicable regulations in an FDA-regulated, cGMP manufacturing environment. This role plans and conducts internal and external audits, oversees supplier and vendor qualification programs, manages corrective actions, and supports regulatory inspection readiness. The position works closely with internal departments and external partners to drive continuous improvement in quality and compliance while contributing to a strong, values-driven company culture. Responsibilities Plan, schedule, and execute internal and external audits to assess compliance with applicable regulations and company quality standards. Audit external suppliers, including contract manufacturing organizations (CMOs), and maintain the vendor qualification program, including the Approved Vendor List within Qualityze. Manage external vendors responsible for conducting international audits and ensure their activities align with company quality and compliance expectations. Oversee the supplier corrective action request (SCAR) program and ensure timely and effective resolution of supplier-related quality issues. Manage and maintain all documents related to audits, vendors, and suppliers within the Quality Management System (QMS), including Qualityze. Assess audit findings, determine the level of risk, and follow up on corrective and preventive actions to ensure both short-term corrections and long-term preventive measures are implemented. Develop and implement performance tracking systems and reporting tools to monitor departmental compliance and audit performance. Prioritize workload to ensure that audits, reports, and follow-up activities are completed accurately and on time. Support the implementation of the Corrective and Preventive Action (CAPA) program where necessary, including investigations and follow-up activities. Train and assist internal departments to understand and comply with quality and compliance expectations, policies, and procedures. Assess the internal audit process by identifying and prioritizing areas of risk for non-compliance and assist in developing or executing processes and policies to reduce that risk. Support training and readiness activities for regulatory inspections, including preparation of documentation and coordination with relevant departments. Provide ongoing support to other Quality Assurance team members to meet departmental and company quality objectives. Report audit metrics and trends to Quality Assurance and departmental leadership to support data-driven decision-making. Communicate effectively with all levels of the organization and across departments, fostering collaboration and a strong team environment. Understand the roles and responsibilities of contract manufacturing organizations and provide Quality Assurance support for product development, investigations, and CAPAs as required. Utilize and remain familiar with Quality Assurance functions in SAP to support quality and compliance activities. Perform other duties as assigned to support Quality Assurance and overall company objectives. Essential Skills Minimum of 5 years of Quality Assurance auditing experience in a cGMP environment. Minimum of 5 years of external vendor and supplier compliance auditing experience within an FDA-regulated industry. Proven experience conducting both internal and external audits. Experience working in manufacturing environments, including exposure to clean rooms. Strong understanding of cGMP principles and FDA-regulated industry practices. Proficiency with computer software applications, including the Microsoft Office Suite. Ability to stand, walk, push, and pull in a variety of environments, including manufacturing areas and clean rooms. Ability to wear all required Personal Protective Equipment (PPE) appropriate to the auditing environment. Ability to travel approximately 20–30% for domestic audits, sometimes with limited notice, and flexibility for potential international travel as needed. Strong adaptability and flexibility in a dynamic quality and compliance environment. Demonstrated initiative and a proactive approach to identifying and resolving quality and compliance issues. Excellent interpersonal skills with the ability to build and maintain strong relationships with operations teams and suppliers. B.A. or B.S. degree in a science or technical field. Additional Skills & Qualifications Knowledge of FDA regulat