QA Systems & Compliance Technical Manager TPM6059

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

• Bachelor's degree in Pharmaceutical Sciences, Process Engineering or related discipline.
• 10-15+ 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.