Compliance Manager

vor 3 Wochen

Council of the City of Sydney, Österreich Discover International Vollzeit

Associate Director - Quality & Technical Operations Europe About the Company: Our client is a leading pharmaceutical manufacturer dedicated to delivering high‑quality medicines that improve patient lives. With a strong focus on operational excellence, regulatory compliance, and continuous improvement, they are expanding their Quality organization and seeking a GMP Compliance Manager to strengthen site compliance and inspection readiness. The Role: As GMP Compliance Manager, you will play a key role in ensuring that all manufacturing, testing, and quality operations are conducted in full compliance with global regulatory standards (EU GMP, FDA, ICH). You will lead compliance activities, support internal and external inspections, and drive a culture of quality and accountability across the organization. Key Responsibilities Act as the site lead for GMP compliance, ensuring adherence to applicable regulatory and company standards. Manage and oversee self‑inspection and internal audit programmes, ensuring timely closure of observations and CAPAs. Support and host regulatory inspections and client audits, ensuring full readiness and professional representation of site operations. Monitor, assess, and implement changes in regulatory requirements and industry guidelines. Partner with cross‑functional teams (QA, QC, Production, Engineering) to proactively identify and mitigate compliance risks. Lead GMP training initiatives and promote a strong compliance culture throughout the organization. Prepare and review key compliance metrics and quality reports for senior management. Qualifications & Experience Degree in Pharmacy, Life Sciences, or a related scientific discipline. Minimum 5 years of experience in a GMP‑regulated pharmaceutical or biopharmaceutical environment. Strong understanding of GMP, FDA principles. ated experience in managing audits, inspections, and compliance programmes. Excellent communication and stakeholder management skills. Fluent in English; additional languages are an advantage. Seniority level Mid‑Senior level Employment type Full‑time Job function Manufacturing Industries Pharmaceutical Manufacturing Biotechnology Research #J-18808-Ljbffr

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