Quality Systems Manager
Are you an experienced Quality Systems professional looking to take ownership of a Pharmaceutical Quality System within a regulated manufacturing environment? This permanent opportunity is based in Sligo and offers the chance to lead GMP quality systems, influence site-wide quality standards and drive continuous improvement across a pharmaceutical operation. Salary: 70 - 80k DOE.
About Your New Employer
Your new employer operates within the pharmaceutical manufacturing sector, with a strong focus on product quality, regulatory compliance and maintaining robust manufacturing standards.
Three reasons this role could appeal:
Take ownership of a broad range of pharmaceutical quality systems rather than focusing on one area of QA.
Work closely with quality and cross-functional teams, influencing how quality processes are managed across the site.
Play an active role in strengthening regulatory compliance, improving systems and preparing the organisation for inspections.
About Your New Job
You will report directly to the Quality Manager.
In this role, you will:
Manage and continuously improve the Pharmaceutical Quality System (PQS), covering deviations, Corrective and Preventive Actions (CAPA), change control, complaints, risk management, document control, training and audit management.
Oversee deviations and quality investigations, assess their impact, approve appropriate CAPAs and address recurring issues or weaknesses in existing procedures.
Support and coordinate regulatory inspections and internal or external audits, ensuring quality systems and supporting documentation are inspection-ready.
Monitor quality performance through Key Performance Indicators (KPIs) and quality metrics, identifying trends and opportunities to improve processes.
Write, review and update Standard Operating Procedures (SOPs), deliver training to new employees and ensure procedures remain aligned with current regulatory requirements.
Work with internal departments, vendors, contractors and suppliers to maintain quality standards, support departmental objectives and drive improvements across the manufacturing operation.
What You Need
Essential:
A relevant advanced degree in Biological Sciences, Pharmaceutical Sciences or a closely related discipline.
6–8 years' relevant experience within the pharmaceutical or biotechnology industry, including at least 2–3 years managing GMP Quality Systems.
Strong knowledge of EU Good Manufacturing Practice (GMP), Pharmaceutical Quality Systems and regulatory requirements, including European Medicines Agency (EMA) and International Council for Harmonisation (ICH) guidelines.
Previous experience managing or coordinating regulatory inspections, alongside a strong understanding of risk-based Quality Assurance strategies and quality management processes.
A strong working knowledge of industry compendia and standards, including United States Pharmacopeia (USP) and European Pharmacopoeia (Ph. Eur.).
Nice to have:
Experience with digital transformation initiatives within quality systems.
Experience working with EU veterinary medicinal product regulations.
A track record of leading teams, improving Quality Assurance processes and resolving significant quality or technical challenges.
You will also need strong problem-solving, communication and organisational skills, with the ability to influence stakeholders, manage competing deadlines and work effectively across departments. Excellent Microsoft Office skills, particularly Word, Excel, PowerPoint and Outlook, and fluency in written and spoken English are required.
What's On Offer
Salary: 70 - 80k DOE
Permanent role.
What's Next
Apply now by clicking the Apply button. Not ready to apply, or have some questions first? Email: pbrowne@sigmar.ie
