Quality Consultant - Health Authority Audit Remediation & Batch Record Review

Mantell Associates is partnered with a leading biopharmaceutical manufacturer based in Munich, who is seeking an experienced Quality Consultant to support ongoing health authority audit remediation efforts and conduct comprehensive batch record reviews .This role is crucial in ensuring compliance with regulatory expectations and in strengthening the site’s quality oversight following recent inspections.Quality Consultant – Responsibilities :Lead and support remediation activities following findings from recent health authority audits (e.g., EMA, FDA, local authorities)Perform detailed batch record reviews for manufacturing and packaging processes to ensure GMP complianceIdentify gaps, deviations, and inconsistencies within documentation and drive corrective and preventive actions (CAPAs)Collaborate with QA, QC, production, and regulatory teams to implement robust quality improvementsContribute to quality system updates and documentation improvements in line with global regulatory requirementsPrepare audit-ready documentation and support mock audits or re-inspections, if neededQuality Consultant – Requirements :Degree in Life Sciences, Pharmacy, or a related fieldMinimum of 8 years’ experience in a GMP-regulated biopharmaceutical or pharmaceutical environmentStrong expertise in audit remediation, batch documentation review, and quality system complianceExperience working in response to EMA, FDA, or other regulatory inspectionsExcellent knowledge of EU GMP and international regulatory standardsFluent in English; German language skills are a strong advantageAble to work on-site in Munich (hybrid options may be considered for the right candidate)Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700. #J-18808-Ljbffr