Quality Assurance Manager/RP – EU

You will act as the Management Representative, responsible for overseeing quality activities across Europe. This individual will ensure the implementation and ongoing development of Quality Management Systems across all divisions, including Sourcing, Clinical Trial Services, Distribution, Medical Devices, and Regulatory

Responsibilities:

• Ensure compliance with all relevant EU standards and legislative requirements and promote and establish a robust quality culture within the organization.
• Lead and mentor the quality team in Ireland and collaborate with the global QA team to implement and develop Electronic Quality Management and Integrated Management Systems.
• Oversee all RP-related duties and manage regulatory, customer, and vendor inspections.
• Implement and maintain training programs across all organizational divisions.
• Administer the Change Control process, ensuring compliant implementation of all GxP changes.
• Review and approve Corrective and Preventive Actions (CAPA), including monitoring, follow-up, and evaluation of CAPA effectiveness.
• Oversee QA responsibilities under the Manufacture and Importation Authorization (MIA), including Qualified Person (QP) duties, ensuring GMP adherence.
• Lead QA responsibilities for Packaging and Labelling activities, ensuring compliance.
• Conduct validation/qualification of GMP Equipment/Systems/Facilities.

Required Experience:

• Minimum of 3 years of QA experience in clinical trials, pharmaceuticals, or medical devices.
• Strong understanding of European regulations and guidelines.
• Diploma or Degree from an accredited institution or equivalent professional experience.
• Supervisory experience is an advantage.
• Experience with Electronic Quality Management Systems (e.g., TrackWise).

To find out more, please contact Patricia Sousa (patricia.Sousa@lifescirecruitment.com)

At Life Sciences Recruitment Ltd (LSR), we are a Global Life Science recruitment firm that specialises in partnering with start-ups, fast-growing biotech and pharmaceutical organisations.

Founded in 2021, we recognised the need for a company with the insights, knowledge and credibility of a search firm but offering a contingent service.

As one of the most competitive and fast-paced industries globally, succeeding and growing in the life sciences business requires a combination of creativity, technical expertise, and business savvy. At LSR, to find the best talent for your organisation, our dynamic recruitment consultants tap into our unparalleled network of contacts and apply a quality-based approach to a contingent search model tailored to your needs. We provide the most sought after candidates to fit your requirements ranging from temporary placement to Fortune 500 companies!

LSR is a privately owned and independent recruitment company focused on the Life Sciences industry. We are a subsidiary of Morgan Prestwich (MP), Europe’s leading boutique Life Sciences executive search and advisory firm.

Contact us today to learn more about our recruitment services.