Head of Global Complaints, Product Quality Risk & Incident Management

Chiesi Group; Parma; Ibrido; EUR 80.000 - 120.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company in Italy is seeking a Head of Global Complaints, Product Quality Risk & Incident Management to oversee global product complaints and quality risks. This leadership role will ensure compliance with high-quality standards across production sites while fostering collaboration with various stakeholders. Candidates should possess over 15 years of experience in quality management, excellent leadership skills, and expertise in regulatory requirements.

Competenze

• Extensive experience (15+ years) in quality management and complaints handling.
• In-depth knowledge of regulatory requirements (FDA, EMA).
• Proven track record in managing complex complaint events and processes.

Mansioni

• Oversees global management of product complaints and quality risk.
• Leads strategy for managing product complaints effectively.
• Coordinates Global Incident Response Committee (GIRC) processes.

Conoscenze

Leadership

Communication

Data Analysis

Formazione

Bachelor's degree in a relevant field

Descrizione del lavoro

Head of Global Complaints, Product Quality Risk & Incident Management

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Head of Global Complaints, Product Quality Risk & Incident Management

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Join to apply for the Head of Global Complaints, Product Quality Risk & Incident Management role at Chiesi Group

Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience, operating in 30 countries with more than 6,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group researches, develops and markets innovative drugs in its main therapeutic areas: Discover more here

We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a recognition of high social and environmental standards. We are a reliable company that adopts and promotes a transparent and ethical behavior at all levels.

We believe that the success of Chiesi is built and shaped by our people and our strong set of shared Values and Behaviors. Our people make a critical difference to our success, which is why it is vital that we attract and retain the right talent who will continue to enrich our culture by living and breathing our values and behaviors.

We are committed to embrace diversity, inclusion and equal opportunities. In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.

Chiesi Global Manufacturing Division

Chiesi Group has three production plants:

Parma (Italy), the strategic hub for the production and distribution of our products, serving as an international supply center with exports to over 80 countries. Here, solid medicines such as tablets and dry powders for inhalers, solutions and suspensions for inhalations and sterile suspension vials for endotracheal administration are produced.

In 2024, a new Biotech Centre of Excellence has launched in Parma. The new facility is dedicated to developing and producing monoclonal antibodies, enzymes, and other proteins.

Blois-La Chaussée Saint Victor plant (France), a center of excellence specializing in the production of Dry Powder Inhalers and Metered Dose Inhalers (MDIs). The site manages direct distribution to customers in the French market and exports to other markets, effectively meeting both local and international needs.

Santana de Parnaiba (Brazil), specialized in the production of pressurized solutions and suspensions for inhalation therapy (pMDIs). Additionally, it has an area dedicated to nasal sprays for the European market. Santana produces pressurised solutions and suspensions for inhalation therapy (MDI).

In 2025, a new investment in Nerviano (Italy) has been announced with the construction of a new facility which will be primarily dedicated to manufacturing carbon minimal inhalers (reinforcing the company’s commitment to both patients’ health and sustainable healthcare solutions), dry powder inhalers and sterile biological products.

Purpose

The ideal candidate will be responsible for overseeing the global management of product complaints, coordinating the escalation process (GIRC), and supervising the product quality risk management of products.

This position plays a crucial role in ensuring the highest standards of product quality and customer satisfaction across all production sites, subsidiaries, and partners.

A small global team reports to this role.

Main Responsibilities

1. Global Complaints Management:

• Leads the global strategy for handling product complaints, ensuring timely and effective resolution.
• Develops and implement standardized processes for complaint intake, investigation, and resolution. Ensure a suitable escalation process is in place and is effective
• Monitors and analyzes complaint data to identify trends and areas for improvement.

2.Escalation Process Coordination (GIRC):

• Coordinates the Global Incident Response Committee (GIRC) process, ensuring that all escalations are managed efficiently and effectively.
• Serves as the primary point of contact for escalations, facilitating communication between relevant stakeholders.
• Ensurs that all escalations are documented, tracked, and resolved in accordance with company policies and regulatory requirements.

3.Quality Risk Management:

• Owns and oversees the global quality risk management program, aimed at identifying and mitigating potential risks to product quality - in alignment with the Chiesi Risk Management process.
• Develops and implement risk management strategies and processes.
• Collaborates with cross-functional teams to ensure that quality risks are identified, assessed, and managed throughout the product lifecycle.
• Ensures a product quality risk management outcome is reviewed on a regular basis by senior management (eg via Quality Council meetings or Risk Review Board meetings) and adequate improvement actions are defined as applicable

4.Influence and Collaboration:

• Works closely, together with the Head of Global Complaints management, with production sites, subsidiaries, and partners and CMOs to ensure alignment with global quality standards and processes for the handling of complaints.
• Provides guidance and support to local and global quality teams, fostering a culture of continuous improvement.

Experience Required

• Extensive experience (15+ years) in quality management, complaints handling and risk management in global roles.
• In-depth knowledge of regulatory requirements and industry standards related to product quality and complaints management (e.g., FDA, EMA, ICH, PIC/S).
• Proven track record of successfully managing complex complaint and risk management events and driving continuous improvement initiatives.

Preferred:

• Management of teams (also in dotted line settings) with members based in multiple countries
• Experience with sterile/aseptic manufacturing environments.
• Familiarity with post-marketing quality surveillance and integration with pharmacovigilance.
• Experience in multiple Risk Management models and tools (ref ICH Q9)
• Track record of successful inspection readiness and participation in regulatory inspections.
• Experience with the platform Veeva

Education

Bachelor's degree in a relevant field (e.g., Quality Management, Engineering, Life Sciences).

Skills

• Excellent leadership and communication skills, with the ability to influence and collaborate with stakeholders at all levels in a multicultural environment.
• Ability to analyze complex issues and make data-driven, risk-based decisions.

Languages

Location

Hybrid, with potential travel to various production sites and subsidiaries as required.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Pharmaceutical Manufacturing

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