R&D QA GCP Manager (Parma, IT)

Biopharma Careers; Parma; Ibrido; EUR 47.000 - 57.000; Tempo pieno

Vantaggi offerti da questo lavoro

Pension

Private medical insurance

Wellbeing programme

Flexible benefits

Restaurant vouchers

Descrizione del lavoro

Chiesi Research & Development in Parma seeks a QA GCP reference person for clinical projects. You will ensure GCP compliance and maintain quality systems in GCP areas.

The role covers QA inputs to study design, execution and reporting, review of study documents, and interaction with regulatory authorities. English proficiency is required; pharma or CRO experience preferred.

Competenze

• Preferably 3+ years as clinical QA in pharma or CROs.
• Alternatively 3+ years in clinical studies as CRA or Project Manager in pharma or CROs.
• English proficiency in written and spoken communication.

Mansioni

• Act as QA GCP reference person in clinical project teams and support study design and reporting.
• Review documents related to clinical studies (protocol/amendment, patient information sheet, consent forms, CSR).
• Manage Suspected Serious Breaches and support GCP inspections from Regulators.
• Address GCP deviations and ensure compliance with current regulations.
• Draft SOPs and instructions for R&D QA GCP activities.
• Review SOPs for clinical studies to ensure regulatory compliance.

Conoscenze

GCP knowledge

English proficiency

Formazione

Pharmacist or Life Sciences degree

Strumenti

Office

Descrizione del lavoro

About us

Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. More than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. Discover more here.

At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. This fosters a culture of reliability, transparency, and ethical behaviour at every level. As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact.

Diversity and inclusion are at the heart of who we are. We believe our differences make us stronger. We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better.

Chiesi Research & Development

Our R&D team represents a fundamental asset for the business. It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, global technical development, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, R&D project and portfolio management. Headquartered in the new purpose-built and fully integrated Research and Development Centre in Parma (Italy), the team also has important operations in Paris (France), Chippenham (UK), Cary (US), Stockholm (Sweden), Toronto (Canada) and Shanghai (China).

Who we are looking for

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.

This role is eligible to participate in an annual bonus scheme, subject to company and individual performance.

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

No matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way.

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.

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.