Group Quality ManagerJob Description/Role ProfileSims IVFSims IVF is one of the leading fertility clinics in Ireland. Since 1997, we have cared for thousands of patients needing treatment to realise their dream of having a baby and have helped pioneer IVF technology in Ireland. We strive to bring the joy of a family to those who need help with their fertility and to assist people in a confidential, professional, and caring manner. Our mission is to provide hope to all those that need help starting families.Sims IVF became part of the Virtus Health family in 2014. As part of Virtus Health, one of the world's leading fertility groups, we share experience and knowledge from around the world, ensuring you get access to the very best reproductive medical care.Summary of RoleThe Sims Group Quality Manager, under the guidance of the Head of Quality Risk andCompliance, is responsible for leading the Quality team in ensuring that all Tissues and Cells are donated, procured, tested, processed, preserved, stored and distributed in accordance with the requirements of Directive 2004/23/EC (and associated annexes), SI 158 of 2006, 598 of 2007 other relevant Irish Legislation, HPRA guidelines and best practice so as to ensure quality, safety and efficacy.The Sims Group Quality Manager is also responsible for ensuring that the requirements of ISO9001:2015 and CHKS accreditation are adhered to. The role holder will be responsible for the day-to-day management of the Quality team and the delegation and review of work.The role holder will support and manage the Quality team to ensure the QMS is maintained, updated, and continually improved.QMS function responsibilities are consistent throughout the group.The following key attributes should be demonstrated:ProfessionalismClarity and concisionStrong written and verbal communication skillsPeople management skillsAbility to Influence and SupportSims Group Quality Manager Job Description / Role Profile1. Transactional Relationships1.1 Line Management – This role will directly report to the Head of Quality, Risk &Compliance.1.2 Key Interdependencies:Responsible PersonHead of QualityQuality teamSenior management teamXentra Pharm team.External Bodies – Key Point of Contact2. Key Areas of ResponsibilityAuditsRegulator engagement and audit management.Lead the internal audit program.Manage Quality team resources to undertake scheduled audits.Prepare audit checklists.Notify auditees of pending audits.Lead audit team audits as directed by schedule.Communicate the audit schedule to all concerned.Review and report on audit results.Tracking and Trending of audit findings.DocumentationManage controlled documentation.Monitor the implementation of SOP 's.Publish SOPs for the Group.Ensure review of procedures takes place in accordance with Quality Manual.Ensure QMS registers up to date.QMS & PerformanceNon-conformance and patient complaint investigation and management.Change control management.Non-conformance / complaint / change control sign off and approval.Complaint letter review and approval.Prepare quality and KPI reports as required.Maintain and report non-conformances on Riskman.Consult with insurers and legal team as required in relation to complaints.Consult with Virtus Australia – including reports & updates.Support the Head of Quality Risk and Compliance with Serious Adverse Event-Management.MeetingsFacilitate and lead Quality Team meetings.Prepare documentation and reports for meetings as required by Head of Quality Risk andCompliance.Team ManagementDay to Day Management of the Quality team, including carrying out regular performance management reviews.Carry out the required quality training for the team.Manage annual leave in line with policy.Motivate and support the team.Organisational TrainingEnsure training is completed by all staff including mandatory.Ensure documented training plans are in place at Sims IVF Group for each department/ including mandatory training.Ensure training files for each department are collated and maintained accordingly.Ensure training events are recorded on Q-Pulse and that attendance is recorded.Ensure appropriate EU Tissue and Cell Directive training workshop are run.Suppliers:Ensure an effective programme for supplier evaluation is in place and that contracts are managed and reviewed to achieve efficiency and good relations.Ensure that Sims IVF requirements are met in terms of expectations and cost. Chair and organise supplier review meetings.Information TechnologyStrong competence in the use of Microsoft office.Strong competence in the use of all aspects of patient databases.Xentra PharmAct as Responsible Person for Xentra Pharm.Ensure that the conditions of the Wholesale Distribution Authorisation (WDA), EU 2013/C343/01 Guideline and current HPRA Guidelines, national legislation on GDP are complied with by Xentra Pharm Management/staff and that a Quality System is implemented and maintained.Focus on the management of authorised activities and the accuracy and quality of records.Ensure that initial and continuous training programmes are implemented and maintained.Coordinate and promptly perform any recall operations for medicinal products.Ensure that relevant customer complaints are dealt with effectively.Ensure that suppliers and customers are approved.Approve any subcontracted activities which may impact on GDP.Ensure that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place.Sims Group Quality Manager Job Description / Role ProfileMaintain appropriate records of any delegated duties.Decide on the final disposition of returned, rejected, recalled, or falsified products.Approve any returns to saleable stock.Ensure that any additional requirements imposed on certain products by national law are adhered to.Managing all inspection from the Regulator (HPRA)Health & SafetyAwareness of and compliance with responsibilities under the 2005 Safety, Health andWelfare at Work act including all subsequent revisions as per the Law Reform Commission.Ensure that the workplace you are responsible for and the means of entering and leaving it are safe and without risks to health.Participate in H&S committee meetings.Take reasonable care of your own health & safety.Take reasonable care for the health and safety of others who may be affected by your actions or omissions at the workplace.Co-operate with Virtus Health Ireland with respect to any action taken by the organisation to comply with the 2005 Safety, Health, and Welfare at Work Act.Systematically report any and all incidents, hazards and near miss, in line with HAS.Essential CriteriaEducational – Degree level qualification in a Quality, legal or related fieldProfessional Experience A minimum of 3 years' experience in a supervisory/management role in a related fieldCore Behavioural Competencies.Personal LeadershipActs with honesty and integrity at all times.Has a realistic sense of self and impact on others.Demonstrates patience and perspective in dealing with difficult situations.Accepts ownership of role and accepts accountability of role objectives.TeamworkWorks co-operatively and effectively with colleagues from our own and other departments with different skills and objectives to achieve the best outcome.Listens and respects other points of view.Open to learning and passing on better ways of doing things.Open to innovative ideas with an ability to follow and implement protocols and procedures and clinic initiatives with his/her clinic colleagues.Attention to DetailEnsures that one's own and others' work and information are complete and accurate.Follows required procedures to ensure high quality of work.Verifies information.Carefully reviews and checks the accuracy of information provided by others.Motivating Others /People ManagementAcknowledges and thank people for their contributions.Expresses pride in the Sims Group and encourages people to feel good about their accomplishments.Signals own commitment to a process by personally supporting key strategies and events.Assists team with development needs.Effective CommunicationEnsures regular and consistent communication takes place.Uses appropriate communication styles.Communicates ethically and demonstrates credibility.Identifies and manages misunderstandings.Manages conflict effectively.LanguagesFluency in English language – Advanced level - written and verbal.DesirableExperience in Good Distribution Practice.Experience in healthcare sector.Terms and Conditions of EmploymentContract – PermanentPlace of Work The role holder's normal place of work will be at Sims IVF Clonskeagh. Clinic visits toSims, Swords and Cork Clinic is a requirement.Working Hours Weekly hours - between the core hours of 8:00 and 18:00, Monday to Friday(Additional overtime hours may be required)Salary - €60,000- €65,000 DOEApplication DetailsPlease submit a cover letter.Also, a copy of an up-to-date CVEmail subject Line- Quality Manager RolePlease email to: Closing date for this recruitment will be 5pm December 10th 2025Sims Group Quality Manager Job Description / Role ProfileJob Type: Full-timePay: €58,000.00-€65,000.00 per yearBenefits:Bike to work schemeCompany pensionOn-site parkingAbility to commute/relocate:Clonskeagh, CO. Dublin: reliably commute or plan to relocate before starting work (required)Work Location: Hybrid remote in Clonskeagh, CO. Dublin