QA Systems & Compliance Technical Manager

IrishJobs

Cork, Cork, Ireland

Cork, Cork, Ireland

Über

Summary: A QA Systems & Compliance Technical Manager is required for a biopharmaceutical company in Cork. The successful candidate will act as a business process manager for applicable quality systems. Responsibilities: Act as a business process manager for applicable quality systems. Assess GMP and regulatory compliance risk areas and develop and implement risk mitigation measures in conjunction with the accountable parties. Work with key stakeholders to identify and implement system improvements. Analyse performance through metrics and trending. Troubleshoot issues and support the business with queries. Benchmark leading practices & identify opportunities to enhance systems. Liaise with global colleagues to share learnings to ensure consistency across the network and alignment with global processes. Provide QA review and/or approval for Supplier Management and other Quality System activities impacting GxP operations, including (but not limited to): deviations, changes, specifications and technical / quality agreements. Provide additional support to Quality Systems and Compliance team. Support audit and inspection activities for site, including preparation, participation, and follow up actions. Lead activities associated with the site quality management review process. Other duties as assigned. Qualifications & Experience: Bachelors degree in Pharmaceutical Sciences, Process Engineering or related discipline. 1015+ years experience within GMP-regulated pharmaceutical or biotechnology environments 3-5 years in leadership roles, with experience in people management and a proven ability to influence cross-functional teams and stakeholders. Significant hands-on experience supporting regulatory inspections. Knowledge of EU GDP Guidelines and regional regulatory requirements. Proven ability to lead change initiatives and drive improvements within and across functions which enable compliance and mitigate risk.

TLNT1_IJ

Cork, Cork, Ireland

Sprachkenntnisse

English

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