Quality and Compliance GMP Auditor

Duties and Responsibilities • Conduct risk-based GMP audits of CMOs, CROs, laboratories, and other contracted suppliers to assess compliance with regulatory requirements and industry standards. • Review pre-audit documentation, coordinate audit activities, and prepare for on-site and remote audits. • Produce comprehensive audit reports, documenting findings, observations, risks, and recommendations, and ensure timely follow-up on corrective actions. • Evaluate manufacturing processes, quality systems, validation activities, product testing, and supporting documentation for GMP compliance. • Assess the effectiveness of supplier Quality Management Systems (QMS), including change control, deviation management, CAPA, and document control processes. • Identify compliance gaps and areas for improvement, working with internal teams and suppliers to develop and implement remediation plans. • Maintain current knowledge of GMP regulations, FDA requirements, industry guidance, and best practices to support compliance initiatives. • Serve as a subject matter expert on GMP and quality compliance, providing training, guidance, and audit-readiness support to Quallent staff. • Support the development and maintenance of Quallent’s Quality Oversight Program, including risk assessments, gap analyses, and mitigation strategies. • Collaborate with cross-functional teams and leadership to advance quality and compliance objectives and perform other related duties as assigned. Education & Experience • Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline. • 2 to 5 years of experience in the pharmaceutical, biotechnology, or medical device industry, preferably in Quality Assurance (QA), Quality Control (QC), Regulatory Affairs, or a related quality function. • A minimum of 4 years of experience in pharmaceutical compliance and quality systems management is preferred, including hands-on QA and regulatory experience. • Demonstrated experience conducting GMP audits as an internal auditor, third-party auditor, or independent consultant. • Experience auditing both oral solid dosage (OSD) and sterile manufacturing facilities is preferred; exposure to biologics and/or biosimilars is highly desirable. • Strong knowledge of current Good Manufacturing Practices (cGMP) and U.S. Food and Drug Administration (FDA) regulations applicable to human pharmaceutical products. • Experience conducting both on-site and remote pharmaceutical audits. • Experience interacting with and responding to regulatory agencies, particularly the U.S. Food and Drug Administration (FDA). • Strong analytical, problem-solving, and risk assessment skills, with the ability to identify compliance gaps and recommend effective corrective actions. • Excellent communication and stakeholder management skills, with the ability to work collaboratively across quality, regulatory, and operational teams. Salary Range: USD$90-000 - USD$145,000 per annum. Quallent offers a highly competitive benefits package.