QA GMP Senior Auditor

Chiesi Farmaceutici S.p.A.; Parma; Hybrid; EUR 52,000 - 65,000; Full time

Benefits offered by this job

Pension

Private medical insurance

Wellbeing programme

Flexible benefits

Relocation support

Job summary

Chiesi Farmaceutici S.p.A. in Parma, Italy, is seeking an experienced QA Auditor to support first and second party audits, supplier qualification, and Quality Agreements within a GMP-driven global R&D environment.

Based in Parma with a flexible hybrid arrangement, you will collaborate across CMC, Regulatory Affairs, Clinical Supply and Procurement to ensure sterility and biotech product standards are met, and you will mentor external consultants when needed.

Qualifications

• Minimum three years of auditor experience in pharmaceutical companies.
• Experience in QA, supplier qualification or audit activities in pharma development/manufacturing.
• Knowledge of GMP requirements.
• Knowledge of auditing techniques.
• Knowledge of sterility assurance for sterile/biotech products.
• Fluent English, written and spoken.
• Proficiency with Microsoft Office (Word/Excel/Outlook/PowerPoint).
• Leadership and teamwork abilities.

Responsibilities

• Plan and execute second party audits of GMP suppliers and service providers.
• Execute first party audits.
• Monitor follow-up of audit non-conformities and CAPA closures.
• Coordinate external consultants supporting Auditing & Supplier Qualification.
• Define, review and finalize Quality Agreements with GMP suppliers.
• Support hosting of GMP inspections.
• Collect and review data for Management Review and KPIs.
• Standardize SOPs related to auditing and qualification processes.
• Organise and support training on GMP requirements.
• Act as QA reference for audits involving sterile, biological and biotech products.
• Interact with cross-functional teams (CMC, Regulatory, Clinical Supply, Procurement).

Skills

Fluent English

GMP knowledge

Auditing techniques

Sterility assurance

Leadership

Organisational skills

Independent judgement

Teamwork

Networking

Decision making

Listening skills

Efficiency orientation

Microsoft Office

PowerPoint

Education

Pharmacy, Chemistry, Biology, Biotechnology, Pharmaceutical Sciences or related

Tools

EDMS

QMS IT systems

Job description

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 supports the execution of first and second party audits, the qualification and maintenance of R&D suppliers and service providers, and the definition and management of Quality Agreements.

The position includes a dedicated focus on sterile, biological and biotech products.

Experience in gene therapies or related advanced platforms is considered a plus.

You will be responsible for

• Plan and execute second party audits of GMP suppliers and GMP service providers (CMOs , contract laboratories).
• Execute first party audits.
• Monitor the follow-up of audit non-conformities and verify the adequacy and timely closure of corrective and preventive actions.
• Manage and coordinate external consultants supporting the Auditing & Supplier Qualification - GMP & Medical Device Unit.
• Define, review and finalise Quality Agreements with GMP suppliers and service providers.
• Support the hosting of GMP inspections.
• Collect and review data for Management Review and KPIs/ metrics.
• Finalize, review and standardise SOPs related to auditing and supplier/service providers qualification processes.
• Organise and support training on GMP requirements and related procedures.
• Act as QA reference for audit and qualification activities supplier/service providers involving sterile, biological and biotech products.
• Interact with CMC, Regulatory Affairs, Clinical Supply, Procurement and other cross-functional teams to what concerns qualification of the above listed providers.

You will need to have

• Scientific degree, preferably in Pharmacy, Chemistry, Biology, Biotechnology, Pharmaceutical Sciences or a related scientific discipline.
• At least three years of experience as auditor in pharmaceutical companies.
• Experience in Quality Assurance, supplier qualification or audit activities within pharmaceutical development and/or manufacturing environments.
• Knowledge of GMP requirements
• Knowledge of auditing techniques
• Knowledge of sterility assurance principles and GMP compliance expectations for sterile and biotech products.
• Leadership, organisational skills, stress management, independent judgement and objectivity, team working, networking, decision making, listening skills and orientation to efficiency.
• Fluent English, written and spoken.
• Good knowledge of Microsoft Office tools, including Word, Excel, Outlook and PowerPoint.

We would prefer for you to have

• Experience in sterile manufacturing, biotech or biological product environments is strongly preferred.
• Consider experience in gene therapies, advanced therapy medicinal products, viral vectors, cell-based products as an additional advantage.
• Familiarity with EDMS and other QMS IT systems is preferred.

Compensation Range

The budgeted salary range approved for this role is between €52.000 and €65.000. This range reflects the typical compensation expected for candidates with the experience and expertise required for the position.

Final offer may vary based on the selected candidate's skills, experience, qualifications, overall profile, 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.

Location

The position is based at our headquarters in Parma and offers a flexible hybrid working arrangement.

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.