R&D QA GCP Manager - Parma, Emilia-Romagna, Italy

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/783h9i

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, we offer a comprehensive benefits package including pension, private medical insurance, wellbeing programme, flexible benefits programme, tivcket restaurant and more.

What We Offer

We provide top‑class benefits, including comprehensive healthcare programs, work‑life balance initiatives, and robust relocation support. Our salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market. Additionally, we offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive.

Equal Employment Opportunity

Chiesi is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business. All qualified applicants receive consideration for employment based on attitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other basis protected by applicable laws. This policy applies to all aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits, and termination.

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/783h9i