Quality Systems Leader: Drive GMP Compliance & Improvement

Sigmar Recruitment; Sligo; On-site; EUR 70,000 - 80,000; Full time

Benefits offered by this job

Competitive salary

Career progression

Supportive team environment

Job summary

Sigmar Recruitment is partnering with a leading pharmaceutical manufacturer in Sligo to recruit a Quality Systems Manager who will oversee the Pharmaceutical Quality System (PQS) ensuring GMP and regulatory compliance.

The role leads deviations, CAPA, change control, audits, and training, with emphasis on risk management, document control, and cross-functional collaboration to sustain high quality standards.

Qualifications

• 6+ years experience in the biotech or pharmaceutical industry.
• 2+ years experience managing GMP Quality Systems.
• Advanced degree in Biological or Pharmaceutical Science discipline.
• Experience managing inspections by regulatory bodies and demonstrated leadership in quality management.
• Expertise in EU GMP, regulatory inspections, risk-based QA strategies, and an understanding of industry regulatory standards (USP / Ph. Eur, GMP, EMA, ICH).
• Excellent communication, collaboration, and time management skills.
• Proficiency with MS Office (Word, Excel, PowerPoint, Outlook) and quality/ERP systems.

Responsibilities

• Oversee management, maintenance, and continual enhancement of the Pharmaceutical Quality System (PQS) to ensure GMP and regulatory compliance.
• Lead and improve key quality systems including deviations, CAPA, change control, complaints, risk management, document control, training, audit management, and management reviews.
• Support and facilitate regulatory inspections, monitor quality system performance through KPIs and metrics, drive continuous improvement initiatives.

Skills

GMP QA experience

Biotech/Pharma experience

Regulatory inspections

Quality metrics/KPIs

Cross-functional leadership

Communication & collaboration

MS Office proficiency

Education

Advanced degree in Biological or Pharmaceutical Science

Tools

Quality/ERP systems

Job description

Sigmar Recruitment is partnering with a leading pharmaceutical manufacturer in Sligo to recruit a Quality Systems Manager who will oversee the Pharmaceutical Quality System (PQS) ensuring GMP and regulatory compliance.

The role leads deviations, CAPA, change control, audits, and training, with emphasis on risk management, document control, and cross-functional collaboration to sustain high quality standards.