QA Systems & Compliance Technical Manager TPM6059

Tandem Project Management Ltd.; Cork; On-site; EUR 90,000 - 120,000; Full time

Job summary

Tandem Project Management Ltd. in Cork seeks a QA Systems & Compliance Technical Manager to act as the business process owner for key quality systems. The role focuses on GMP/regulatory risk assessment, system improvements, and cross-functional collaboration across the biopharma network.

The candidate will lead quality reviews, support audits, and drive changes that enhance compliance and performance. This senior position requires extensive GMP experience and strong leadership in a global,

Qualifications

• 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 cross-functional influence.

Responsibilities

• Act as a business process manager for applicable quality systems.
• Assess GMP and regulatory compliance risk areas and implement mitigations.
• Collaborate with stakeholders to identify and implement system improvements.
• Analyze performance through metrics and trending.
• Provide QA review/approval for quality activities impacting GxP operations.
• Support audit and inspection activities for site and prepare follow-ups.
• Lead activities within the site quality management review process.

Skills

GxP compliance

Regulatory risk assessment

Leadership

Stakeholder collaboration

Quality systems governance

Education

Bachelor’s degree in Pharmaceutical Sciences, Process Engineering or related discipline

Tools

Quality Management Systems

Job description

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.