Quality System Manager

Excellent opportunity for a QA Systems Manager with a Leading Life Sciences company in Sligo. The Quality Systems manager will manage and improve the site's Pharmaceutical Quality System, ensuring GMP and regulatory compliance across deviations, CAPA, change control, complaints, risk management, documentation, training and audits.

Overview of your responsibilities:

• Support audits and regulatory inspections.
• Develop and improve Quality Systems.
• Manage deviations and approve CAPAs.
• Monitor KPIs and quality metrics.
• Write and update SOPs.
• Ensure compliance with EU veterinary regulations.
• Resolve quality issues through risk-based decision-making.
• Build strong cross-functional relationships.
• Address system gaps and implement corrective actions.

Knowledge, Skills and Experience Required for the Role:

• 6-8+ years' biotech/pharma experience.
• 2-3+ years managing GMP Quality Systems.
• Strong regulatory inspection experience.
• Proven Quality leadership and problem-solving skills.
• Expertise in EU GMP and risk-based QA.
• Experience improving and digitalising Quality Systems.
• Strong team leadership and continuous improvement skills.
• Knowledge of USP, Ph. Eur., EMA and ICH standards.