Quality Manager

Sims 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 and Compliance,  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 ISO 9001:2015 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:·    Professionalism·    Clarity and concision·    Strong written and verbal communication skills·    People management skills·    Ability to Influence and SupportXentra Pharm is part of the Virtus Health / Sims IVF group that procures, handles, stores and supplies medicinal products for human use to retail pharmacies in accordance with European Directives, Irish Legislation and HPRA Guidelines on Good Distribution Practice. This role will require the Sims Group Quality Manager to act as the responsible person for Xentra Pharm and to line manage Xentra Pharm operations.  1.     Transactional Relationships 1.1   Line Management – This role will directly report to the Head of Quality, Risk & Compliance. 1.2   Key Interdependencies:·      Responsible Person ·      Head of Quality ·      Quality team ·      Senior management team·      Xentra Pharm team2.     Key Areas of Responsibility QMS & Performance·      Non-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.·      Liaise with insurers and legal team as required in relation to complaints.·      Liaise with Virtus Australia – including reports & updates.·      Support the Head of Quality Risk and Compliance with Serious Adverse Event-         Management. Xentra Pharm Act as Responsible Person for Xentra Pharm.Ensure that the conditions of the Wholesale Distribution Authorisation (WDA), EU 2013/C 343/01 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.Maintain 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 inspections from the Regulator (HPRA) Audits ·     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.  Documentation·      Manage controlled documentation.·      Monitor the implementation of SOP ‘s.·      Publish SOP’s for the Group.·      Ensure review of procedures takes place in accordance with Quality Manual.·      Ensure QMS registers up to date. External Bodies – Key Point of Contact·      Regulator engagement and audit management.·      Prepare and submit HPRA licence variation applications  Meetings·   Facilitate and lead Quality Team meetings.·   Prepare documentation and reports for meetings as required by Head of Quality Risk and Compliance. Team Management·   Day 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 Training·   Ensure training is completed by all staff.·  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 QPulse 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 Technology ·   Strong competence in the use of Microsoft office.  ·   Strong competence in the use of all aspects of patient databases.Health & Safety·  Awareness of and compliance with responsibilities under the 2005 Safety, Health and Welfare 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.·  Take reasonable care for 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.