Quality Systems And Compliance Manager

Sigmar Recruitment

Galway

Quality Systems and Compliance Manager. The Quality Systems and Compliance Manager will work across the quality system lifecycle from design through post market surveillance collaborating with partners in all functions including R&D, Design Assurance, Supply Chain, Clinical, Marketing, Regulatory and Commercial to ensure roles and responsibilities and accountabilities are clear in the implementation of a best in class quality system. What you will do: Establish, implement, and maintain the IDEM Quality Management System, providing direction and support to all functions, manufacturing sites, commercial entities, in areas of design quality, production and process controls, distribution quality, post market activities. Lead and co-ordinate the Company QMS Integration project across both manufacturing and commercial sites, working with the Site project leads to ensure project plans are in place and tracking to milestone targets. Represent IDEM quality and take an active role in participating on Project Steering teams to ensure that project oversight and governance is in place and effective. Develop strong communications with both the ARDx divisional Quality Systems lead and the company’s’ Corporate quality systems group (AQR). Collaborate closely with both groups to ensure internal requirements are understood and consistently deployed across IDEM sites as well as co-ordinating the annual ARDX/AQR audits at IDEM sites. Work with the IDEM sites and QA leads (manufacturing & commercial) to plan, prepare, and manage all quality system audits both internal as well as external Regulatory inspections. Develop the knowledge and understanding of all staff regarding quality system requirements and provide the appropriate training to functional experts who are accountable for the delivery of quality system requirementsCollaborate effectively with cross-functional colleagues to ensure that the IDEM quality system meets the company Policies and Standards as well as all external regulatory requirements. Work closely with the IDEM RA team to understand changes in regulatory requirements that may impact the quality system and develop effective communications with key regulatory agencies such as World Health Organisation, Notified Bodies, NMPA, FDA, and all other applicable authorities.   What you will need: Bachelor of Science/Engineering or related discipline. Minimum 10 years work experience, including at least 5 years in a regulated environment (IVD/Medical. Devices/Pharma), with minimum of 3 years in a Quality management role. Strong understanding and experience in the implementation of ISO 13485, ISO 14971, IVDR/MDR. quality system requirements, FDA QSR’s, as well as key global regulations – TGA/PMDA/NMPA/WHO. Strong communication skills and ability to influence peers and Senior Management. Collaborate effectively across functions and deliver results through people engagement. Develop staff in quality system requirements and ensure strong capability/competence levels. Ability to build an effective quality system, and efficient processes that support BU/Site business objectives.     What you will receive: Competitive Salary & Comprehensive Benefits Package, Training & Development.    To apply for this position please contact Chloe Walsh at Sigmar Recruitment T: +353 91 455305 E:   chloe.walsh@sigmar.ie    All applications will be treated with the strictest of confidence.  Sigmar will never forward your CV to a third party without prior consent.  .

1255 days ago