Quality Assurance Associate

Quality Assurance Associate | Global Biotech | Ireland | Remote | Permanent

Location: Ireland (Fully Remote – occasional travel and availability to attend the Dublin site when required)

Salary: Up to €40,000 (depending on experience)

Employment Type: Permanent, Full-Time

APX Life Sciences is partnering with an established, growing global biotech company looking to appoint a Quality Assurance Associate to join its international Quality Assurance team.

This is a fantastic opportunity for a QA professional with 2+ years of industry experience who is looking to develop their career within a global biotech, gaining broader exposure to pharmaceutical quality systems, regulatory compliance and international quality operations.

The position offers a fully remote working arrangement within Ireland, working closely with an experienced global Quality team to support the maintenance of the company's Quality Management System (QMS), GMP/GDP compliance and ongoing inspection readiness.

The successful candidate will also act as a local point of contact for regulatory inspections in Ireland, so must be able to attend the Dublin site at short notice when required.

With continued international growth and a collaborative, entrepreneurial working environment, this position offers excellent opportunities to develop broader QA expertise and take on greater responsibility over time.

Key Responsibilities

• Support the maintenance and continuous improvement of the company's global Quality Management System (QMS).
• Assist with the preparation, review and maintenance of SOPs, work instructions and controlled quality documentation.
• Support electronic Quality Management System (eQMS) activities, including document control, version management and archiving.
• Assist with the tracking and management of deviations, CAPAs, change controls and quality complaints.
• Support internal audits, supplier qualification activities and ongoing inspection readiness.
• Act as the designated local contact for the Health Products Regulatory Authority (HPRA), facilitating site access and documentation reviews during inspections.
• Maintain accurate quality records, training documentation and compliance trackers.
• Support GMP and GDP quality activities across the wider global organisation.
• Work closely with senior QA colleagues to ensure quality activities are completed accurately and in line with regulatory requirements.

What We're Looking For

• 2+ years of experience within Quality Assurance, Quality Systems or a related function in the pharmaceutical, biotechnology or regulated life sciences industry.
• Good working knowledge of GMP and GDP principles.
• Experience supporting Quality Management Systems and controlled documentation processes.
• Familiarity with deviations, CAPAs, change controls and audit preparation.
• Experience using an electronic Quality Management System (eQMS) would be advantageous.
• Knowledge of HPRA requirements and regulatory inspections would be beneficial.
• A degree in Life Sciences, Pharmacy, Chemistry or a related scientific discipline.
• Strong organisational skills, attention to detail and excellent communication skills.
• A proactive, reliable and adaptable mindset, with a willingness to learn and take on broader responsibilities.
• Must be permanently based in Ireland and able to attend the Dublin site at short notice when required.

What's on Offer?

• Competitive salary of up to €40,000, depending on experience.
• Fully remote working arrangement within Ireland.
• Pension scheme and private medical insurance.
• Annual leave and additional employee wellbeing benefits.
• Opportunity to gain exposure to global pharmaceutical quality operations.
• Direct collaboration with an experienced international Quality Assurance team.
• Broad exposure to GMP/GDP compliance, quality systems and regulatory inspections.
• Excellent opportunity for professional development and increased responsibility within a growing global biotech.
• A collaborative, entrepreneurial environment with a strong focus on quality, accountability and long-term career development.

This opportunity would particularly suit a QA Associate or Quality Systems professional who enjoys working in a hands-on environment and is keen to broaden their experience within an international biotech organisation.

Interested in learning more?

Please send your CV to Lewis Wolfe at lewis@apxls.com or contact Lewis directly at APX Life Sciences for a confidential discussion.