Quality Assurance Manager

Job Title: QA Manager

Location: Dublin, Ireland

As the Quality Assurance Manager, you will be the key representative responsible for overseeing all quality-related activities across the European operations. This is a crucial leadership position where you will play a significant role in maintaining and enhancing the Quality Management Systems. You’ll collaborate closely with global teams to ensure consistent quality practices across various locations, driving their commitment to excellence.

Key Responsibilities:

• Ensure adherence to all relevant European standards and regulations, maintaining the highest levels of compliance.
• Cultivate and lead a strong quality culture within the organisation, with a focus on continuous improvement and operational excellence.
• Manage and develop the quality team based in Ireland, providing guidance and support to ensure their success.
• Work alongside the global QA team to implement and refine the Electronic Quality Management System (EQMS) and Integrated Management Systems.
• Oversee regulatory, customer, and vendor inspections, ensuring all processes meet the required standards.
• Ensure that robust training programs are established and maintained across all divisions, supporting ongoing professional development.
• Manage the Change Control process, ensuring all GxP-related changes are implemented according to established SOPs.
• Review, approve, and track Corrective and Preventive Actions (CAPA), ensuring their effectiveness and timely completion.
• Lead QA responsibilities under the Manufacture and Importation Authorization (MIA), ensuring compliance with GMP.
• Oversee QA responsibilities for packaging and labelling activities, ensuring all processes meet quality standards.
• Conduct validation and qualification of GMP equipment, systems, and facilities.
• Foster effective communication across departments to ensure seamless information flow.

Qualifications/ Experience:

• Minimum of 3 years in QA roles within clinical trials, pharmaceuticals, or medical devices sectors.
• Deep understanding of European regulations and guidelines.
• Degree or equivalent in a relevant field, with hands-on experience in the industry.
• Proficiency in MS Office applications; experience with EQMS platforms is a plus.
• Previous supervisory experience and a proven ability to lead and develop teams.
• Strong focus on accuracy, with excellent decision-making and problem-solving abilities.
• Exceptional communication skills, both written and verbal, with the ability to engage effectively across different global time zones.
• Willingness to travel as needed and adapt to varying work environments.