Head of Global Complaints, Product Quality Risk & Incident Management

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

Fluent English

Location

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

Soft Skills