Quality Systems Manager

Collins McNicholas Recruitment; Sligo; On-site; EUR 90,000 - 130,000; Full time

Job summary

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

The role requires 6–8+ years in biotech/pharma and 2–3+ years managing GMP Quality Systems, with strong leadership and regulatory inspection experience.

Qualifications

• 6–8+ years in biotech/pharma
• 2–3+ years managing GMP Quality Systems
• Strong regulatory inspection experience
• Proven quality leadership and problem-solving skills
• Experience improving and digitalising Quality Systems
• 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.
• Drive continuous improvement.
• Write and update SOPs.
• Ensure compliance with EU veterinary regulations.
• Resolve quality issues thru risk-based decisions.
• Build strong cross-functional relationships.
• Address system gaps and implement corrective actions.

Skills

GMP knowledge

Quality leadership

Risk-based QA

Cross-functional collaboration

Documentation

Education

Advanced Biological/Pharmaceutical Sciences degree

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.
• Drive continuous improvement.
• 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.
• Advanced Biological/Pharmaceutical Sciences degree.
• 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.

For a confidential discussion and more information on the role contact Courtney Russell

[e-mail]

[phone]