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, you will 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.
• You will support and facilitate regulatory inspections, monitor quality system performance through KPIs and metrics, and drive continuous improvement initiatives across the organization.
• You will write, review, and revise SOPs, provide training to new employees, and collaborate cross-functionally to maintain high standards.
• You will 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.

What's Next

Apply now by clicking the “Apply Now” button or contact me, Ross Keyes, on 091749269 or rkeyes@sigmar.ie for a confidential discussion.
If this job isn’t quite right but you are seeking a similar opportunity, please get in touch. We have multiple roles available across temporary, FTC, and permanent positions.