Quality Management System’s Manager

4 semanas atrás

Lisboa, Portugal Fundação Champalimaud Tempo inteiro

**Quality Management System’s Manager****:
**Localização**: Centro Champalimaud**Entidade Empregadora**: Fundação Champalimaud**Regime**: Tempo Inteiro**Posição**: Técnico**Início da Candidatura**: 17 Nov. 2023**Fecho de Candidatura**: 15 Dez. 2023A leadership role within the Quality Management System (QMS) responsible for the delivery of quality compliance for the Botton-Champalimaud Pancreatic Cancer Centre.

Main duties will include
- Responsible for establishing, implementation and continual improvement of the QMS for the BCPCC in accordance with International Organisation for Standardization (ISO) 9001.
- Oversee the development, implementation, and compliance tracking of Quality Assurance (QA).
- Lead the creation and documentation of QA procedures for the BCPCC, including writing new SOPs and guidelines and creating tools, to ensure that the BCPCC meets all regulatory requirements, and documents are complete and accurate.
- Coordinate the review of existing documents in accordance with specified review timelines, updating existing documents as required.
- Implement appropriate QA strategies and continually improve the QMS to provide assurance that trials are conducted in accordance with the protocol.
- Establish an independent internal audit programme. The QA Department will set up the audit programme and conduct the audits. To be independent the QA Department wil not be involved in normal operational functions such as sample processing or trial monitoring.
- Support the delivery of clinical research in accordance with GCP and GDPR in accordance with the EU Clinical Trial Regulations and EU Regulations on Blood, Tissues and Cells (BTC), and applicable local regulations.
- Maintaining quality management systems at least to ISO EN DIN 9001 and ideally ISO EN DIN 17025/15189 for clinical laboratory testing and in vitro diagnostic test systems that are aligned with the requirements for risk management (ISO 22367), the requirements for laboratory safety (ISO 15190) and the requirements for sample collection and transport (ISO 20658.1), as well as information security (ISO 27001).
- Support stakeholders with QA, regulations, ethics, and privacy inquires.
- Work with the internal audit programme to learn from the reporting of any serious breaches, major or critical findings, or suspicion of fraud or misconduct as per Centre procedures.
- Maintain confidentiality.
- Responsibility for the management of quality events and Corrective and Preventive Actions (CAPAs) and trend analysis of issues.
- Ensure the production of regular reports and information to the senior management team, identifying quality GCP risks and working with stakeholders to design mitigation strategies.
- QA will include quality checking/maintaining processes to ensure that files are kept up to date.
- The internal audit programme will be responsible for performing internal and external audits. This includes deciding what needs to be audited, planning audits, performing audits, and making recommendations for improvements to senior management.
- Develop checking processes for vendor qualification that the provider has all the necessary processes in place to deliver the contract and comply with regulatory requirements. This would include contracted out activities such as Investigational Medicinal Product (IMP) assembly, Qualified Person (QP) release and distribution, and translation services for international trials. Develop a QA team including identifying key roles, developing job descriptions, hiring, and training new staff as appropriate.
- Responsible for delivering QMS training to centre staff and any other QA related training as required.
- Undertake line management duties, recruitment and selection of staff, and training of staff within the team. Perform personal development reviews.
- Evaluate training needs and conduct performance reviews for assigned staff.
- Keep abreast of current legal requirements, internationally accepted standards, and developments in the professional field.
- Organise and lead team meetings to ensure appropriate resource allocation and timely completion of QA tasks.
- Analyse, plan, and track project activities, communicating progress on a regular basis to all relevant stakeholders, including maintaining meeting minutes, timelines and shared documentation.
- Identify and efficiently resolve issues and risks to stakeholders in a timely and clear fashion.
- Track estimated project costs and provide budget updates to relevant stakeholders.
- Develop positive relationships with internal teams and stakeholders.
- Any other duties as directed by the Line Manager applicable to the role.

Standards of Performance
- Excellent team management, ensuring that staff perform to a high level and that they are appropriately trained and developed in their roles.
- Proactively looking for opportunities to improve service provision and subsequent delivery on the improvements identified.
- All individuals are expected

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