R&D QA GCP Manager

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/78ch18

Department: Global R&D; Quality Assurance
Business Area: Quality
Job Type: Direct Employee
Contract Type: Permanent
Location: Parma, Italy
This Is What You Will Do
- Ensure the GCP compliance within the project teams, acting as QA reference person in the clinical project teams.
- Ensure the implementation and maintenance of the quality system in the GCP areas.

You Will Be Responsible For
- Acting as QA GCP reference person in the clinical project teams, both related to organic and inorganic growth, providing QA inputs and supporting the clinical study teams in the design, execution and reporting of clinical studies.
- Reviewing the documents related to clinical studies (protocol/amendment, patient information sheet/Informed consent form, CTS label, CTS instruction for use, CSR).
- Managing the Suspected Serious Breaches.
- Supporting the preparation, management and follow‑up of GCP inspections from Regulatory Authorities.
- Managing the GCP deviations.
- Writing the SOPs and working instructions related to the activities performed by R&D; QA GCP.




- Reviewing the SOPs and working instructions related to the clinical studies, in order to ensure the compliance with the current regulations.

You Will Need To Have
- Preferably: At least 3 years’ experience as clinical QA, in pharmaceutical companies or clinical CROs.
- Alternatively: At least 3 years’ experience in clinical studies working as CRA or Project Manager, in pharmaceutical companies or clinical CROs.
- Scientific degree, Pharmacist or Life Sciences.
- English deep knowledge, both oral and written.

Technical Skills
- Knowledge of GCP regulations.
- Use of common computer tools (e.g. Office).

Location
Based in Parma, with the possibility of a hybrid working arrangement.
Compensation Range
The minimum salary for this role is €52,000, aligned to our established salary framework. The final offer will reflect the candidate’s skills, experience, qualifications and internal equity considerations.
Benefits
In addition

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/78ch18