Quality Systems Manager

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

Quality Systems Manager

About Your New Employer

• Join a leading pharmaceutical manufacturer in Sligo dedicated to excellence in continuous improvement.
• Be part of a site with a strong track record in regulatory compliance, innovation, and quality-driven operations.
• Work within a collaborative team environment where leadership, expertise, and initiative are highly valued.

About Your New Job

• As the Quality Systems Manager,youwill oversee the management, maintenance, and continual enhancement of the Pharmaceutical Quality System (PQS) to ensure GMP and regulatory compliance.
• As the Quality Systems Manager you will lead and improve key quality systems, including deviations, CAPA, change control, complaints, risk management, document control, training, audit management, and management reviews.
• Youwill support and facilitate regulatory inspections, monitor quality system performance through KPIs and metrics, and drive continuous improvement initiatives across the organization.
• Youwill write, review, and revise SOPs, provide training to new employees, and collaborate cross-functionally to maintain high standards.
• Youwill influence and lead on quality-driven decision making, proactively addressing system weaknesses and ensuring effective corrective actions.

What Skills You Need

• 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.

What's on Offer

• Highly competitive salary (€70,000 to €80,000) + benefits
• Opportunities for professional development and meaningful career progression.
• Dynamic, supportive work environment focused on continuous improvement.