Quality System Manager

Collins McNicholas Recruitment & HR Services Group; Sligo; On-site; EUR 70,000 - 95,000; Full time

Job summary

Collins McNicholas Recruitment & HR Services Group is seeking a QA Systems Manager in Sligo to lead and improve the Pharmaceutical Quality System, ensuring GMP and regulatory compliance across deviations, CAPA, change control, complaints, risk management, documentation, training and audits.

The role involves supporting audits, developing quality systems, managing deviations, monitoring KPIs, and maintaining SOPs, with a strong emphasis on EU GMP and risk-based QA.

Qualifications

• 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.

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.

Skills

Biotech/pharma experience

GMP Quality Systems

Regulatory inspections

Leadership & problem solving

Job description

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.