Quality Manager & EU RP

Job Description

Responsible for the quality and compliance processes for Henry Schein Ireland and for supporting the UK Quality Team with QMS and GDP related topics, this person will uphold the required regulatory requirements in order to maintain product and QMS licenses, certification and the approvals needed to conduct Henry Schein's current and future business activities. The role holder will also take the lead and have the have specialist knowledge to manage and fulfil our required EU Responsible Person activities ensuring pharmaceutical supply into the Irish market meets applicable requirements and obligations. The role holder will need to seamlessly blend technical subject matter expertise with an accessible approach to communicating and guiding non-technical stakeholders in the importance of maintaining and delivering our quality, compliance and regulatory requirements, whilst working independently.

• To act as the EU GDP Responsible Person to uphold the activities listed in the Dublin Ireland WDA license and related business activities. To act as the key contact with HPRA to manage licensed requirements in line with Irish legislation and guidance.
• To fulfill the responsibilities of the EU GDP RP by ensuring:
  • The HPRA guidelines on Good Distribution practice are trained out and complied with.
  • the Operations do not compromise the quality of the medicines
  • an adequate Quality system is maintained
  • suppliers and customers are approved
  • oversight of the audit of the quality system and to carry out independent audits
  • that adequate records are maintained
  • all personnel are trained
  • customer complaints are dealt with effectively
  • disposition of returned, rejected, recalled or falsified product
  • full and prompt cooperation with marketing authorisation holders in the event of a recall.
  • RP required competencies obtained and refreshed routinely.
• To manage HSUK & HSIE Quality Management System, QMS, to ensure processes are efficient and effective and are in compliance with applicable regulations and standards to maintain both QS and Product Licenses and approvals.
• To strategically manage the internal audit/self-assessment program for our range of product and activities across UK & Ireland, ensuring that audits are planned and performed by risk, in line with business needs, and auditors competencies are current and in place. Ensure that findings are addressed in a timely manner and areas where improvement is needed are elevated to the management review and line manager.
• To manage and maintain QMS ensuring that all processes and activities within its scope of activity are maintained and in compliance with the business strategic approach and all regulatory requirements such as defined in the GDP section 2
• Manage QMS quality system compliance obligations, certification, product storage and transportation requirements for all groups of product and service relationships. Ensuring agreements are implemented and maintained and audited to verify compliance status.
• Management of any critical suppliers and or outsourced service provision through maintenance of agreements, procedures and routine assessments.
• Manage the Risk Management process, ensuring that a program of risk assessment is conducted in line with business activities and risks identified. Ensuring that risks are ranked and elevated at appropriate intervals and associated corrective actions are routinely managed and documented.
• To manage the adverse events, recalls, field safety communications, and complaints relating to product and services, ensuring Q&R oversight of process and timeliness of actions needed.
• To manage the CAPA process ensuring CAPAs are documented and completed in a timely manner. Ensuring effectiveness of actions taken by completing follow up audits where deemed necessary.
• Establish, maintain and oversee a consistent QMS culture within HSUKH and HS Ireland.
• To lead the Management Review Process, engaging the management team to uphold leadership responsibility and authority designated. Manage the periodic publication of quality policy and objectives and associated management of agreed KPIs.
• Compilation and management of QMS KPIs data and continuous improvement initiatives to increase the efficiency and effectiveness of the QMS and operational activities.
• Conduct, host and coordinate inspections of the organization and its critical suppliers, taking part in any due diligence targets and inspections as needed.
• To manage routine business operational requirements, Q&R key contribution in to processes and business strategies such as for tenders, environmental sustainability, continuous improvement projects and compliance programs.
• Ensure that the organization's regulatory affairs activities are conducted accurately, ethically, and according to relevant regulations, laws, and standards.
• Contributing to product compliance initiatives and associated audits and verification activities needed to stay abreast of compliance requirements.
• Conduct and oversee quality/GDP/pharmacovigilance training and compliance communications. Monitor and verify the performance of the E-Learning programs where deemed appropriate and in line with our compliance obligations.
• Ensure that the interfaces between Regulatory and Quality and other departments are managed optimally.
• This role is extremely varied; therefore, the job description is not exhaustive, and the role holder will be required to participate in other duties as required by the business.

• Bachelor's degree in Regulatory Affairs / Life Sciences/Environmental Sciences or related field preferred
• Or demonstrable, qualified by experience, Manager level knowledge of medical/pharmaceutical industry
• Accredited auditor qualification desirable

• Henry Schein suite of compliance training upon commencement of role

• Extensive Regulatory Affairs and Quality System experience, preferably in the medical device industry and or pharmaceutical industry.
• Managing compliance to/working within ISO 9001 and ISO 13485 quality management systems
• Lead Auditor or Internal Auditor experience
• Managing compliance to/working within Good Distribution Practice requirements.
• Communicating with Regulatory Bodies and hosting compliance inspections
• EU & UK MDR and GDP Requirements
• experience of GDP requirements
• Experience of Pharmacovigilance systems and requirements
• Experienced in hosting regulator audits/inspections
• Familiarity with risk Management principles and ability to implement and maintain routine QRM program.
• Thorough knowledge of EU/UK Good Distribution Practices and Pharmacovigilance requirements, including management of Licenses and Approvals needed for pharmaceutical, medical devices, biocides and consumable product.
• Good knowledge of MDD 93/42/EEC / EU MDR 2017/745 compliance requirements
• Experience in completing Quality Management System compliance assessments and continuous improvement for ISO 9001, GDP, PV, MDD/MDR requirements.

• Excellent communication, negotiation, and interpersonal skills.
• Self-starter with the ability to work independently and in a team.
• Strong organizational skills with the ability to manage multiple projects simultaneously.
• Solution oriented and ability to work in an matrix; international environment