Clinical Quality Assurance Manager

2 settimane fa

Siena, Toscana, Italia Philogen A tempo pieno

Job Title: Clinical Quality Assurance Manager (GCP)

Department: Clinical, QA

Philogen S.p.A. is seeking a Clinical Quality Assurance Manager (GCP) to strengthen the office of clinical quality assurance. The successful candidate will be responsible for assessing compliance with SOPs, GxP, European regulations, local regulations and guidelines, and clinical study protocols.

Key Responsibilities:

  • Maintain GCP/ICH compliant systems and processes which control the quality of work and clinical trials conducted in Europe and US.
  • Write and/or review clinical SOPs and support continuous process improvements.
  • Manage training of staff on company procedures, GCP regulations, and documentation systems.
  • Qualify CRO and other vendors related to the clinical activity.
  • Perform documentation control in the TMF and quality reviews of clinical trial essential documents and associated documentation.
  • Perform routine internal System and TMF audits and checks throughout the lifecycle of a trial/program to ensure compliance with internal procedures, as well as regulatory guidelines.
  • Report significant clinical quality deficiencies and/or risks to upper management and actively participate in solving the issues.
  • Perform clinical site GCP auditing activities to ensure that studies are conducted in accordance with sponsor protocols, GCP, industry guidelines, and agency regulations.
  • Lead role to prepare company and clinical sites for customer audits and regulatory GCP inspections.
  • Participate as Subject Matter Expert during regulatory GCP inspections.

Requirements:
  • A good scientific background (ideally Master/ PhD in Biology, Biotechnology, Life Sciences, etc.).
  • Ideally 3-5 years of experience in Clinical Quality oversight (clinical QA experience in the pharmaceutical industry required).
  • A complete understanding and application of principles, concepts and practices of clinical research procedures is required.
  • A high level of English language, both written and spoken.
  • A high level of attention to detail.
  • The ability to work independently, to prioritize her/his own work as well as to prioritize task and coordinate other team members.
  • Excellent interpersonal skills, ability to work in teams, flexibility in changing tasks and priorities and motivation for new challenges.

Job Location: Sovicille, Siena

Interested candidates are kindly asked to send their Curriculum Vitae to the following e-mail address, specifying the job position of interest and authorizing the process of personal data under Italian Legislative Decree 196/03 and General Data Protection EU Regulation (2016/679).

  • Clinical Quality Assurance Manager

    1 mese fa

    Siena, Toscana, Italia Philogen A tempo pieno

    Clinical Quality Assurance ManagerPhilogen is seeking a highly skilled Clinical Quality Assurance Manager to strengthen its office of clinical quality assurance. The successful candidate will be responsible for assessing compliance with SOPs, GxP, European regulations, local regulations, and clinical study protocols.Key Responsibilities:Maintain GCP/ICH...

  • Clinical Quality Assurance Manager GCP Specialist

    2 settimane fa

    Siena, Toscana, Italia Philogen A tempo pieno

    Clinical Quality Assurance Manager GCP Specialist Job DescriptionPhilogen S.P.A. is seeking a highly skilled Clinical Quality Assurance Manager GCP Specialist to strengthen its office of clinical quality assurance. This role will be responsible for ensuring compliance with SOPs, GxP, European regulations, local regulations, and clinical study protocols.Key...

  • Senior Clinical Quality Assurance Professional

    1 settimana fa

    Siena, Toscana, Italia Philogen A tempo pieno

    Job Title: Senior Clinical Quality Assurance Professional**Company Overview:** Philogen S.p.A. is a leading company in the field of clinical quality assurance, and we are seeking a highly skilled Senior Clinical Quality Assurance Professional to join our team.Job Summary: We are looking for an experienced professional to manage GCP/ICH compliant systems and...

  • Gmp Quality Assurance Specialist

    2 settimane fa

    Siena, Toscana, Italia Philogen A tempo pieno

    Job Title: Gmp Quality Assurance SpecialistPhilogen is seeking a Gmp Quality Assurance Specialist to report to the Gmp Quality Assurance Manager and contribute to quality policies in support of Philogen's Quality System.The ideal candidate will be responsible for:• Writing, reviewing, and approving documents (SOPs, PQRs, IMPDs, validation protocols and...

  • Quality Assurance Manager

    3 settimane fa

    Siena, Toscana, Italia Philogen A tempo pieno

    Quality Assurance ManagerPhilogen is seeking a Quality Assurance Manager to join our team. The successful candidate will be responsible for ensuring the quality of our products and processes.Key responsibilities include:Leading the quality control laboratory and ensuring compliance with GMP and GLP regulations.Developing and implementing quality control...

  • GMP Quality Assurance Specialist

    1 mese fa

    Siena, Toscana, Italia Philogen A tempo pieno

    Job Title: GMP Quality Assurance SpecialistDepartment: QAPhilogen S.p.A. is seeking a GMP Quality Assurance Specialist to report to the GMP Quality Assurance Manager and contribute to quality policies in support of Philogen's Quality System.The successful candidate will be responsible for:Writing, reviewing, and approving documents (SOPs, PQRs, IMPDs,...

  • Quality Assurance Manager for Pharmaceutical Development

    1 settimana fa

    Siena, Toscana, Italia GSK A tempo pieno

    Job OverviewThis is an exciting opportunity to join our team as a Quality Assurance Manager, responsible for ensuring the highest standards of quality in pharmaceutical development. Reporting to the Director of Quality Assurance, you will play a key role in developing and implementing quality strategies that drive business growth while maintaining regulatory...

  • GMP Quality Assurance Specialist

    2 settimane fa

    Siena, Toscana, Italia Philogen A tempo pieno

    Job Title: GMP Quality Assurance SpecialistPhilogen S.p.A. seeks a GMP Quality Assurance Specialist to contribute to quality policies in support of the company’s Quality System. The successful candidate will be responsible for: writing, reviewing, and approving documents; revising production and quality control batch records; managing GMP QA operations,...

  • Quality Assurance Specialist

    2 settimane fa

    Siena, Toscana, Italia Gsk A tempo pieno

    About the Role:The Quality Assurance Specialist will be responsible for ensuring that all GSK operations meet the highest standards of quality and compliance.Key Responsibilities:Provide expert advice on quality and compliance matters to cross-functional teams.Develop and implement quality systems and procedures to ensure GSK meets regulatory...

  • Senior Manager, Clinical Sample Management and Oversight

    3 settimane fa

    Siena, Toscana, Italia Csl Seqirus A tempo pieno

    Job SummaryWe are seeking a highly experienced Senior Manager, Clinical Sample Management and Oversight to join our team at Csl Seqirus. The successful candidate will be responsible for ensuring the on-time delivery of sample data and end-to-end central laboratory management across our global Clinical Development portfolio.Key Responsibilities* Establish and...

  • Senior Manager, Bioanalytical and Sample Operations

    3 settimane fa

    Siena, Toscana, Italia Csl Seqirus A tempo pieno

    The Senior Manager; Bioanalytical and Sample Operations is accountable for ensuring the on-time delivery of sample data across the global Clinical Development portfolio of CSL Clinical Trials.Key Responsibilities:Ensuring timely delivery of sample dataDeveloping and implementing laboratory management strategiesLeading a global team of bioanalysts and sample...

  • Senior Software Developer

    3 settimane fa

    Siena, Toscana, Italia Osmosi S.p.A. A tempo pieno

    About the Role:We are seeking a skilled Software Development Professional to join our team at {company}.Key Responsibilities:Develop and maintain software applications using a range of programming languages and technologies.Collaborate with cross-functional teams to identify and prioritize software development projects.Design and implement software solutions...

  • Specialista Assicurazione della Qualità

    3 settimane fa

    Siena, Toscana, Italia Gi Group S.P.A A tempo pieno

    La nostra specializzazione, HRevo LifeScience, è parte di Gi Group S.P.A. e si concentra sulla Ricerca e Selezione di profili qualificati per i settori Operation, Quality, Regulatory, RD, Clinical Research e Sales Marketing farmaceutico e medico.Offerta per un Specialista Assicurazione della Qualità - Master Record di LottoGli sviluppatori di tecnologia di...

  • Executive Assistant Manager in charge of F&B

    4 settimane fa

    Siena, Toscana, Italia Belmond A tempo pieno

    Job Title: Executive Assistant Manager in charge of F&BWe are seeking a highly skilled and experienced Executive Assistant Manager to lead our Food and Beverage operations. As a key member of our hotel team, you will be responsible for ensuring the highest standards of quality and service in all our restaurants, bars, and banqueting facilities.Key...

  • Executive Director of Food and Beverage Operations

    4 settimane fa

    Siena, Toscana, Italia Belmond A tempo pieno

    Job SummaryWe are seeking a highly skilled and experienced Executive Assistant Manager to lead our Food and Beverage team at Belmond Castello di Casole. As a key member of our leadership team, you will be responsible for overseeing the implementation of our F&B strategic goals, managing day-to-day operations, and enhancing the quality of our food and...

  • Manufacturing Process Improvement Leader

    3 settimane fa

    Siena, Toscana, Italia Https:Www.Energyjobline.ComSitemap A tempo pieno

    Job SummaryAs a Manufacturing Process Improvement Leader at McPhy, you will play a key role in driving process capability improvement at our San Miniato plant. Reporting to the Site Manager, you will lead initiatives that focus on enhancing production efficiency, quality, and safety.Responsibilities- Define technical specifications for manufacturing systems,...

  • Supervisore del Sistema di Qualità

    4 settimane fa

    Siena, Toscana, Italia Gi Group Spa Filiale Di Poggibonsi A tempo pieno

    Filiale: PoggibonsiSpecializzazione: Life ScienceHiRevo LifeScience è la specializzazione di Gi Group dedicata alla Ricerca e Selezione di profili in ambito Operation, Quality, Regulatory, R&D, Clinical Research e Sales & Marketing dei settori Farmaceutico e Medicale.Per importante azienda alimentare italiana che commercializza olio di oliva siamo alla...

  • Global Head of Lab Systems Automation

    3 settimane fa

    Siena, Toscana, Italia Gsk A tempo pieno

    Job Summary:This role is responsible for leading the strategy and global end-to-end lifecycle management of Vaccines RD laboratory computerized systems, including robotics and automation solutions.Key Responsibilities:Provide strong leadership and strategic direction to implement and maintain automated and/or computerized systems applications in an...

  • Ingegnere Progetto Junior per Pharma

    3 settimane fa

    Siena, Toscana, Italia Https:Www.Energyjobline.ComSitemap A tempo pieno

    La nostra divisione Life Sciences è leader a livello italiano nell'ambito della consulenza ingegneristica, convalida e servizi GMP per le aziende del comparto farmaceutico, chimico e sanitario. Costituita da consulenti specializzati di elevato livello tecnico e provata esperienza nel campo delle Good Manufacturing Practices, l'azienda assicura una totale...

  • F&B Operations Director

    4 settimane fa

    Siena, Toscana, Italia Belmond A tempo pieno

    About the RoleWe are seeking a seasoned hospitality leader to oversee the Food and Beverage function at Belmond Castello di Casole. As Executive Assistant Manager in charge of F&B, you will be responsible for delivering exceptional guest experiences and driving revenue growth through strategic management of commercial initiatives.Key ResponsibilitiesEnsure...