QA Compliance Lead: Audit Readiness & Regulation

Chanelle Pharma; Loughrea; On-site; EUR 90,000 - 120,000; Full time

Job summary

Chanelle Pharma in Ireland is seeking a QA Compliance Team Lead to drive the site's quality assurance program and ensure inspection readiness. Based onsite in Loughrea, you will oversee audits, data integrity, risk management, pharmacovigilance quality, and the self-inspection program, leading a dedicated team.

You will collaborate with stakeholders to maintain regulatory compliance, implement CAPAs, and promote continuous improvement in quality systems across the site.

Qualifications

• Degree in Quality Assurance, Pharmaceutical Science, Life Sciences or related discipline.
• 5+ years in a QA compliance role within a GMP-regulated environment, with at least 2 years in a leadership position.
• Experience in audit management, data integrity, and risk management.

Responsibilities

• Lead and develop the QA Compliance team to ensure high performance and engagement.
• Allocate resources and prioritize compliance activities to meet business and regulatory objectives.
• Maintain a state of readiness for regulatory inspections and customer audits.
• Plan, coordinate, and manage internal audits and external inspections, including preparation, hosting, and follow-up.
• Ensure timely closure of audit findings and CAPAs.
• Oversee implementation and monitoring of data integrity programs across all systems and processes.
• Ensure compliance with ALCOA+ principles and regulatory expectations for electronic and paper records.
• Lead the site’s quality risk management program, ensuring risk assessments are performed and documented appropriately.
• Provide guidance on risk-based decision-making and mitigation strategies.
• Ensure compliance with pharmacovigilance requirements and support audits related to PV activities.
• Collaborate with relevant stakeholders to maintain PV quality systems.
• Manage the site’s self-inspection program, including scheduling, execution, and reporting.
• Drive continuous improvement based on findings and trends.
• Identify opportunities to enhance compliance processes and implement best practices.
• Monitor regulatory changes and update compliance programs accordingly.

Skills

Quality Assurance

Leadership

Auditing

Regulatory compliance

Risk management

Education

Degree in Quality Assurance, Pharmaceutical Science, Life Sciences

Job description

Chanelle Pharma in Ireland is seeking a QA Compliance Team Lead to drive the site's quality assurance program and ensure inspection readiness. Based onsite in Loughrea, you will oversee audits, data integrity, risk management, pharmacovigilance quality, and the self-inspection program, leading a dedicated team.

You will collaborate with stakeholders to maintain regulatory compliance, implement CAPAs, and promote continuous improvement in quality systems across the site.