Clinical Quality Assurance Manager
3 settimane fa
**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 SOPs, GxP, European regulations, local regulations and guidelines, and clinical study protocols. This position will collaborate with other functions in the Clinical Department.
- 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.
- 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 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
-
Clinical Quality Assurance Manager
7 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...
-
Gmp Quality Assurance Manager
2 settimane fa
Siena, Italia Philogen A tempo pieno**Location: Siena - Italy** *** **Department: QA** *** Philogen S.p.A. is looking for a “**GMP Quality Assurance Manager**” who will report to the Plant Manager and who will give his/her contribution to quality policies in support of Philogen’s Quality System. - implementing and managing the site quality system; ensuring the quality oversight of...
-
Gmp Quality Assurance Manager
2 settimane fa
Siena, Italia Philogen A tempo pieno**Location: Siena - Italy*******Department: QA*****Philogen S.p.A. is looking for a "**GMP Quality Assurance Manager**" who will report to the Plant Manager and who will give his/her contribution to quality policies in support of Philogen's Quality System.- implementing and managing the site quality system; ensuring the quality oversight of site and...
-
Clinical Data Manager
2 giorni fa
Siena, Italia Philogen A tempo pieno**Location: Siena - Italy** *** **Department: Clinical** *** Philogen S.p.A. would like to hire a** CLINICAL DATA MANAGER** to support our Clinical Department. **Responsibilities**: - Perform data cleaning activities on assigned studies - Design paper and/or electronic Case Report Forms (CRFs) in collaboration with the clinical team - Collaborate in...
-
Clinical Research Associate
9 mesi fa
Siena, Italia Philochem AG A tempo pienoJob Title: CLINICAL RESEARCH ASSOCIATE - Location: Siena - Italy - Department: Clinical - Site initiation, monitoring, and close-out in accordance to GCP. - Monitoring visits and site management of national and European centres. - Tracking patient recruitment and enrollment. - Evaluating integrity and quality of patient data and investigator study file. - A...
-
Clinical Trial Start Up Associate
2 settimane fa
Siena, Italia Bespoke Recruitment A tempo pienoJob location**:CORK, IRELAND _(relocation package available for those outside of Ireland)_** **Multinational pharmaceutical company in Cork, Ireland is looking for a **Clinical Trial Associate.** **You are**: - accountable to ensure the investigator sites meet requirements to enrol study participants into clinical trials and support ongoing activities...
-
Clinical Research Associate
3 settimane fa
Siena, Italia Philochem Ag A tempo pienoJob Title: CLINICAL RESEARCH ASSOCIATE- Location: Siena - Italy- Department: Clinical- Site initiation, monitoring, and close-out in accordance to GCP.- Monitoring visits and site management of national and European centres.- Tracking patient recruitment and enrollment.- Evaluating integrity and quality of patient data and investigator study file.- A good...
-
Clinical Trial Start Up Associate
7 giorni fa
Siena, Italia Bespoke Recruitment A tempo pienoJob location**:CORK, IRELAND _(relocation package available for those outside of Ireland)_****Multinational pharmaceutical company in Cork, Ireland is looking for a **Clinical Trial Associate.****You are**:- accountable to ensure the investigator sites meet requirements to enrol study participants into clinical trials and support ongoing activities during...
-
Clinical Research Nurse
17 ore fa
Siena, Italia Barrington James A tempo pienoBarrington James is seeking a highly motivated and experienced Freelance Clinical Research Nurse to support an exciting new project. If you have a strong background in study coordination and patient care, this flexible opportunity—offering 5 hours per month—might be perfect for you!Key Responsibilities:Support patient recruitment at the study center and...
-
Clinical Research Nurse
2 giorni fa
Siena, Italia Barrington James A tempo pienoBarrington James is seeking a highly motivated and experienced Freelance Clinical Research Nurse to support an exciting new project.If you have a strong background in study coordination and patient care, this flexible opportunity—offering 5 hours per month—might be perfect for you!Key Responsibilities:Support patient recruitment at the study center and...
-
Clinical Research Nurse
3 giorni fa
Siena, Italia Barrington James A tempo pienoBarrington James is seeking a highly motivated and experienced Freelance Clinical Research Nurse to support an exciting new project. If you have a strong background in study coordination and patient care, this flexible opportunity—offering 5 hours per month—might be perfect for you Key Responsibilities: Support patient recruitment at the study center and...
-
Intern/junior Quality Assurance Intern
1 giorno fa
Siena, Italia Brainnest A tempo pieno**POSITION**:Quality Assurance Intern **LOCATION**:Remote **SCHEDULE**:Part-time (10-20h/week) **About Brainnest**: Our team is looking for a **Quality Assurance Intern **to join them in the upcoming weeks. This position is great for an aspiring QA professional looking to work on business-critical projects and gain relevant work experience. **Your...
-
Cqa Audit Manager
6 giorni fa
Siena, Italia GSK A tempo pieno**_Be You’ at GSK_** At GSK, we're a company with a purpose to **help people do more, feel better and live longer. **We realise that our purpose starts with us. When we feel at our best, we perform at our best. Therefore, we want all applicants to be able to perform their best throughout the recruitment process. We will be delighted to hear from talented...
-
Quality Control Manager
1 settimana fa
Siena, Italia Philogen A tempo pieno**Location: Siena - Italy** *** **Department**: Philogen S.p.A. would like to hire a **Quality Control Manager **who will report directly to the Plant Manager. Biochemical and Microbiological QC laboratory functions and the corresponding documentation to support the timely disposition of product. - Overall Quality control disposition of incoming materials...
-
Biochemical Quality Control Manager
7 ore fa
Siena, Italia Philogen A tempo pieno**Location: Siena - Italy** *** **Department: **Philogen S.p.A. would like to hire a **Biochemical** **Quality Control Manager **who will report directly to the Quality Control Manager. - Biochemical laboratory functions and the corresponding documentation to support the timely disposition of product. - Overall Quality control disposition of incoming...
-
Quality Control Manager
6 giorni fa
Siena, Italia Philogen A tempo pieno**Location: Siena - Italy*******Department**:Philogen S.p.A. would like to hire a **Quality Control Manager **who will report directly to the Plant Manager.Biochemical and Microbiological QC laboratory functions and the corresponding documentation to support the timely disposition of product.- Overall Quality control disposition of incoming materials and...
-
Senior Quality Assurance Specialist
2 settimane fa
Siena, Toscana, Italia Philogen A tempo pieno**About Philogen S.p.A.**Philogen S.p.A. is a biotechnology company dedicated to the development of innovative treatments for life-threatening diseases, focusing on angiogenesis-related disorders.**Job Summary**We are seeking an experienced **Quality Control Analyst** to join our quality control laboratory team in Siena, Italy.- Develop and maintain cell...
-
Plant Manager
2 settimane fa
Siena, Italia Philogen A tempo pieno**Location: Siena - Italy** *** **Department**: Plant Manager reports directly to Philogen’s CEO and directs and manages all plant operations. The Plant Manager is responsible for the day to day operations of a sterile products manufacturing facility. The role provides daily leadership to the fulfillment of GMP development and production activities as...
-
Plant Manager
9 mesi fa
Siena, Italia Philochem AG A tempo pienoJob Title: PLANT MANAGER & QUALIFIED PERSON - Location: Siena - Italy - Department: Others Plant Manager reports directly to Philogen’s CEO and directs and manages all plant operations. The Plant Manager is responsible for the day to day operations of a sterile products manufacturing facility. The role provides daily leadership to the fulfillment of GMP...
-
Plant Manager
3 settimane fa
Siena, Italia Philochem Ag A tempo pienoJob Title: PLANT MANAGER & QUALIFIED PERSON- Location: Siena - Italy- Department: OthersPlant Manager reports directly to Philogen's CEO and directs and manages all plant operations.The Plant Manager is responsible for the day to day operations of a sterile products manufacturing facility. The role provides daily leadership to the fulfillment of GMP...