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.