Clinical Quality Assurance Manager
1 mese fa
Job Title: CLINICAL QUALITY ASSURANCE MANAGER (GCP)Department: Clinical, QAPhilogen S.P.A., in preparation for the expansion of clinical activities, plans to strengthen the office of clinical quality assurance.
On this regard Philogen is looking for a "Clinical Quality Assurance Manager (GCP)".
The position will be responsible to assess compliance with SOPs, GxP, European regulations, local regulations and guidelines, and clinical study protocols.
This position will collaborate with other functions in the Clinical Department.In particular the successful candidate will be responsible to: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 (including Protocols, Investigator's Brochure, CRFs, etc.)
as appropriate.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.The ideal candidate should have: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, SienaInterested candidates are kindly asked to send their Curriculum Vitae to the following e-mail address ******, specifying the job position of interest authorizing the process of personal data under Italian Legislative Decree 196/03 and General Data Protection EU Regulation (2016/679).#J-18808-Ljbffr
-
Clinical Quality Assurance Manager
4 settimane fa
Siena, Toscana, Italia Philogen A tempo pienoClinical 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
4 settimane fa
Siena, Toscana, Italia Philogen A tempo pienoClinical Quality Assurance Manager (GCP)Philogen S.p.A. is seeking a highly skilled Clinical Quality Assurance Manager (GCP) to strengthen its office of clinical quality assurance. The successful candidate will be responsible for ensuring compliance with SOPs, GxP, European regulations, local regulations, and clinical study protocols.Key...
-
Clinical Quality Assurance Manager GCP Specialist
1 settimana fa
Siena, Toscana, Italia Philogen A tempo pienoClinical 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...
-
Clinical Quality Assurance Manager
6 mesi fa
Siena, Italia Philogen A tempo pienoJob Title: CLINICAL QUALITY ASSURANCE MANAGER (GCP) Department: Clinical, QA Philogen S.p.A., in preparation for the expansion of clinical activities, plans to strengthen the office of clinical quality assurance. On this regard Philogen is looking for a "Clinical Quality Assurance Manager (GCP)". The position will be responsible to assess compliance with...
-
Clinical Quality Assurance Manager
5 mesi fa
Siena, Italia Philogen A tempo pienoJob Title: CLINICAL QUALITY ASSURANCE MANAGER (GCP) Department: Clinical, QA Philogen S.p.A., in preparation for the expansion of clinical activities, plans to strengthen the office of clinical quality assurance. On this regard Philogen is looking for a "Clinical Quality Assurance Manager (GCP)". The position will be responsible to assess compliance with...
-
Clinical Quality Assurance Manager
5 mesi fa
Siena, Italia Philogen A tempo pienoJob Title: CLINICAL QUALITY ASSURANCE MANAGER (GCP)Department: Clinical, QAPhilogen S.p.A., in preparation for the expansion of clinical activities, plans to strengthen the office of clinical quality assurance. On this regard Philogen is looking for a "Clinical Quality Assurance Manager (GCP)" . The position will be responsible to assess compliance with...
-
Clinical Quality Assurance Manager
5 mesi fa
Siena, Italia Philogen A tempo pieno**Location: Siena - Italy** *** **Department: Clinical, QA** *** Philogen S.p.A., in preparation for the expansion of clinical activities, plans to strengthen the office of clinical quality assurance. On this regard Philogen is looking for a **“Clinical Quality Assurance Manager (GCP)”**. The position will be responsible to assess compliance with...
-
Clinical Quality Assurance Manager
2 settimane fa
Siena, Toscana, Italia Philogen A tempo pienoJob Title: Clinical Quality Assurance Manager (GCP)Department: Clinical, QAPhilogen 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...
-
Senior Clinical Quality Assurance Professional
6 giorni fa
Siena, Toscana, Italia Philogen A tempo pienoJob 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...
-
Quality Assurance Manager
3 settimane fa
Siena, Toscana, Italia Philogen A tempo pienoQuality 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 settimana fa
Siena, Toscana, Italia Philogen A tempo pienoJob 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...
-
Gmp Quality Assurance Specialist
1 mese fa
Siena, Italia Philogen A tempo pienoJob Title: GMP QUALITY ASSURANCE SPECIALISTDepartment: QAPhilogen S.P.A. is looking for a " GMP Quality Assurance Specialist " who will report to the GMP Quality Assurance Manager and who will give his/her contribution to quality policies in support of Philogen's Quality System.In particular the successful candidate will be responsible for:writing, reviewing...
-
GMP Quality Assurance Specialist
4 settimane fa
Siena, Toscana, Italia Philogen A tempo pienoJob 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,...
-
Gmp Quality Assurance Specialist
6 mesi fa
Siena, Italia Philogen A tempo pienoJob Title: GMP QUALITY ASSURANCE SPECIALIST Department: QA Philogen S.p.A. is looking for a "GMP Quality Assurance Specialist" who will report to the GMP Quality Assurance Manager and who will give his/her contribution to quality policies in support of Philogen's Quality System. In particular the successful candidate will be responsible for: writing,...
-
Gmp Quality Assurance Specialist
5 mesi fa
Siena, Italia Philogen A tempo pienoJob Title: GMP QUALITY ASSURANCE SPECIALIST Department: QA Philogen S.p.A. is looking for a "GMP Quality Assurance Specialist" who will report to the GMP Quality Assurance Manager and who will give his/her contribution to quality policies in support of Philogen's Quality System.In particular the successful candidate will be responsible for: writing,...
-
Gmp Quality Assurance Specialist
4 mesi fa
Siena, Italia Philogen A tempo pienoJob Title: GMP QUALITY ASSURANCE SPECIALISTDepartment: QAPhilogen S.p.A. is looking for a " GMP Quality Assurance Specialist " who will report to the GMP Quality Assurance Manager and who will give his/her contribution to quality policies in support of Philogen's Quality System.In particular the successful candidate will be responsible for:writing, reviewing...
-
GMP Quality Assurance Specialist
1 mese fa
Siena, Toscana, Italia Philogen A tempo pienoJob Title: GMP Quality Assurance SpecialistPhilogen S.p.A. is seeking a highly skilled GMP Quality Assurance Specialist to join our team. The successful candidate will report to the GMP Quality Assurance Manager and contribute to quality policies in support of our Quality System.Key Responsibilities:Develop, review, and approve quality documents, including...
-
GMP Quality Assurance Specialist
2 settimane fa
Siena (SI), Italia Philogen A tempo pienoJob Title: GMP QUALITY ASSURANCE SPECIALIST Department: QA Philogen S.p.A. is looking for a “GMP Quality Assurance Specialist ” who will report to the GMP Quality Assurance Manager and who will give his/her contribution to quality policies in support of Philogen’s Quality System. In particular the successful candidate will be responsible for: ...
-
GMP Quality Assurance Specialist
1 mese fa
Siena (SI), Italia Philogen A tempo pienoJob Title: GMP QUALITY ASSURANCE SPECIALIST Department: QA Philogen S.p.A. is looking for a “ GMP Quality Assurance Specialist ” who will report to the GMP Quality Assurance Manager and who will give his/her contribution to quality policies in support of Philogen’s Quality System. In particular the successful candidate will be responsible for: ...
-
Siena, Toscana, Italia GSK A tempo pienoJob 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...
