Senior QA GCP Specialist and Auditor

Chiesi Farmaceutici S.p.A.; Parma; Hybrid; EUR 60,000 - 90,000; Full time

Benefits offered by this job

Pension

Private medical insurance

Job summary

Chiesi Farmaceutici S.p.A. in Parma seeks an experienced GCP QA professional to verify compliance, manage CAPAs, and support quality metrics across Global R&D. The role includes audits at clinical studies and with vendors, and oversight of QA documents and training programs.

Responsibilities cover CAPA plans, KPI reporting, TrackWise workflows, and collaboration with Clinical, Pharmacovigilance and Procurement teams. A strong background in GCP and audits is essential for success.

Qualifications

• At least 3 years’ experience in Pharmaceutical/Consultancy/CRO QA in R&D with GCP knowledge.
• At least 2 years of experience as a GCP auditor.
• Knowledge of GCP requirements and quality systems.
• Understanding of the pharmaceutical development process across all trial phases.
• Experience with auditing techniques and training methods.
• Fluent English, written and spoken.

Responsibilities

• Verify and ensure GCP compliance; manage GCP CAPAs and KPIs.
• Prepare quality metrics; support Global R&D quality activities.
• Manage TrackWise and QA documentation; handle supplier/audit workflows.
• Support external consultants for auditing, due diligence and supplier qualification.
• Finalize Quality Documents and SOPs for audits and qualification.
• Write/review SOPs related to audit/qualification of clinical service providers.
• Ensure training on GCP activities and maintain traceability.
• Execute GCP first/second party audits at studies and vendors.
• Finalize and manage GCP audit reports; liaise with Clinical, Pharmacovigilance and Procurement.

Skills

Fluent English

Planning skills

Organizational skills

Strategic thinking

Quality orientation

Tools

TrackWise

Job description

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Department: Global R&D Quality Assurance

Business Area: Quality

Job Type: Direct Employee

Contract Type: Permanent

Location: Parma, IT

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

The role will be responsible to verify and ensure the compliance and the correct application of Good Clinical Practices (GCP) being primarily responsible for the management of all the GCP CAPAs, preparation of the quality metrics, KPIs supporting the compliance inside Global R&D Departments, management of Quality Documents and by execution of first and second party audits at clinical studies and vendors.

You will be responsible for

• Management of CAPA Plans from GCP audits
• Management of the requests for the collection of quality metrics, KPIs supporting Global R&D Departments
• Management of Trackwise/Quality Management system, Suppliers and Audit workflows
• Support the management of external consultants supporting the Auditing, Due Diligence & Supplier Qualification Unit.
• Finalization of Quality Documents supporting the Auditing, Due Diligence & Supplier Qualification Unit.
• Write/Review SOPs relating to audit and qualification of clinical service providers
• Ensure training on GCP relevant activities and procedures
• Ensure good documentation and traceability
• Execution of GCP first and second party audits at clinical studies and vendors
• Finalization and management of the GCP audit reports
• Interact with Clinical Departments, Pharmacovigilance and Procurement

You will need to have

• At least 3 years’ experience in Pharmaceutical, Consultancy Companies or Contract Research Organization in the Research & Development environment Quality Assurance with robust knowledge of GCP supporting clinical trials and knowledge of compliance
• At least 2 years of experience as GCP auditor
• Knowledge of GCP requirements and quality system
• Knowledge of the pharmaceutical development process supporting the whole panel of clinical trials (Phase I, II, III and IV)
• Knowledge of training technique
• Knowledge of auditing techniqueFluent English, written and spoken

Planning and organizational skills

Strategic thinking

• Quality orientation

We would prefer for you to have

• ISO auditor Certification to be considered an added value

Location

ThepositionisbasedatourheadquartersinParmaandoffersaflexiblehybridworkingarrangement.

Compensation Range

The minimum salary for this role is € [X], 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 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.