Senior Pharmaceutical Compliance Auditor
Our client, a reputable pharmaceutical organization, is seeking an experienced Senior Pharmaceutical Compliance Auditor to join their dedicated compliance team in
Milwaukee, Wisconsin, US
. This role is critical in ensuring that the company adheres to the highest standards of quality and regulatory compliance across all its operations. You will be responsible for planning, conducting, and reporting on internal audits of manufacturing facilities, R&D labs, quality control units, and other relevant departments to assess compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other applicable regulations (e.g., FDA, EMA, ISO). The ideal candidate will have a deep understanding of pharmaceutical quality systems and regulatory requirements. Key duties include identifying compliance gaps, assessing risks, and recommending corrective actions. You will work collaboratively with site personnel and management to develop and implement robust corrective and preventive action (CAPA) plans. The Senior Compliance Auditor will also play a role in external audits, preparing sites for regulatory inspections, and potentially auditing contract manufacturing organizations (CMOs) and suppliers. Excellent analytical and investigative skills, combined with strong communication and interpersonal abilities, are essential for this position. You must be able to effectively document audit findings, prepare comprehensive reports, and present results to senior management. This is an exciting opportunity to contribute to the integrity and reliability of pharmaceutical products and to shape the company's compliance strategies. The hybrid work model allows for a balance between on-site auditing activities and remote report generation and planning. Key Responsibilities: Plan and execute internal audits of pharmaceutical operations to ensure GMP/GLP compliance. Assess compliance with relevant national and international regulatory requirements. Identify non-compliance issues, risks, and areas for improvement. Document audit findings and prepare detailed audit reports. Develop and track CAPA plans to address identified deficiencies. Support external audits and regulatory inspections. Evaluate the effectiveness of the company's quality management system. Provide training and guidance on compliance matters to site personnel. Audit contract manufacturers and suppliers as needed. Stay current with evolving regulatory standards and industry best practices. Qualifications: Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field. Minimum of 7 years of experience in pharmaceutical quality assurance, quality control, or regulatory affairs, with a significant portion focused on auditing. In-depth knowledge of GMP, GLP, and other relevant pharmaceutical regulations. Proven experience in conducting internal and/or external audits. Strong understanding of pharmaceutical quality systems. Excellent analytical, critical thinking, and problem-solving skills. Exceptional attention to detail and accuracy in documentation. Strong written and verbal communication skills, with the ability to present findings clearly. Ability to travel as required for on-site audits. Relevant certifications (e.g., ASQ CQE, CQA) are a plus. Apply tot his job Apply To this Job