Head of Quality Systems and Risk Management

Recordati; Milano; Ibrido; EUR 72.000 - 88.000; Tempo pieno

Descrizione del lavoro

Recordati is seeking a Head of Quality Systems and Risk Management to provide global leadership and governance of the enterprise QMS and QRM framework across GMP manufacturing, laboratories, supply chain, distribution, and affiliates. The role acts as corporate process owner for quality systems, ensuring compliance, inspection readiness, patient safety and continuous improvement.

The candidate will drive global quality metrics, data integrity strategy, supplier quality, and readiness for major

Competenze

• Minimum 12–15 years of progressive pharmaceutical quality experience including global leadership responsibilities.
• Expertise in QMS governance, risk management, compliance, and cross-functional leadership within multinational pharma.
• Strategic thinking, data-driven decisions, and ability to lead through ambiguity and complexity.
• Strong systems thinking and understanding of interdependencies between quality, manufacturing, supply chain, regulatory and business objectives.
• Proven project leadership to drive governance and continuous improvement of global Quality Systems and Quality Risk Management.

Mansioni

• Govern global Quality Management System and ensure effectiveness of its quality elements (Deviations, CAPA, Change Control, Complaints, Management Review).
• Drive quality metrics, analytics and system trending.
• Lead enterprise Data Integrity strategy and oversight.
• Govern Supplier Quality requirements and performance monitoring.
• Lead inspection readiness programs and support major health authority inspections.
• Establish global risk-based auditing program.
• Support acquisitions, integrations and global harmonization programs.

Formazione

Bachelor degree in Pharmacy, Chemistry, Engineering, Microbiology or related discipline

Descrizione del lavoro

Head of Quality Systems and Risk Management

ID: 2839

Date of Posting: Sep 25, 2026

Business Area: Quality

Job Type: Direct Employee

Territory:

Full-Time or Part-Time: Full Time

Seniority: Mid-senior

At Recordati, we are united by a clear purpose: unlocking the full potential of life. With a century of history behind us, we are building the next chapter of our journey, continuing to grow while keeping patients at the centre of all we do.

What drives us is a shared belief that health, and the opportunity to live life to the full, should be within reach for everyone. This brings energy to our work, shaping how we support each other and show up every day. Our values – Better Together, Never Settle and Always Deliver – reflect this mindset, helping us to keep improving and make a meaningful difference.

Above all, these values bring to life our promise to everyone at Recordati, you can unlock your full potential. We know that people thrive when they can be themselves, are trusted and supported, and are given the opportunity to grow and make a meaningful contribution.

Are you ready to unlock your full potential?

Job Purpose

We are looking for a Manager who provides global leadership and governance of the enterprise Quality Management System (QMS) and Quality Risk Management (QRM) framework across GMP manufacturing, laboratories, supply chain, distribution operations, contract partners and affiliates. This role serves as the corporate process owner for quality systems and ensures compliance, inspection readiness, patient safety, product quality and continuous improvement.

Key Responsibilities

• Govern global Quality Management System and ensure effectiveness of its quality elements e.g. Deviations, CAPA, Change Control, Complaints and Management Review.
• Drive quality metrics, analytics and system trending.
• Lead enterprise Data Integrity strategy and oversight.
• Govern Supplier Quality requirements and performance monitoring.
• Lead inspection readiness programs and support major health authority inspections.
• Establish global risk-based auding program.
• Support acquisitions, integrations and global harmonization programs.

Required Education

Bachelor degree in Pharmacy, Chemistry, Engineering, Microbiology or related discipline required. Advanced degree preferred.

Required Skills and Experience

• Minimum 12-15 years of progressive pharmaceutical quality experience including global leadership responsibilities.
• Demonstrated expertise in QMS governance, risk management, compliance, quality culture transformation and cross-functional leadership within multinational pharmaceutical organizations.
• Enterprise mindset, strategic agility, patient-centric decision making, courageous leadership,accountability, talent development, stakeholder influence, change leadership, operational excellence, data-driven decisions, collaboration across cultures, and ability to lead through ambiguity and complexity.
• Success in this role requires strong systems thinking and the ability to understand the interdependencies between quality, manufacturing, supply chain, regulatory, and business objectives.
• The ideal candidate demonstrates exceptional cross-functional collaboration, building alignment across global stakeholders and external partners.
• Strong analytical problem-solving, risk-based decision making, and communication skills are essential to translate complex quality and compliance matters into clear actions and sustainable outcomes.
• Proven project leadership and execution capabilities are critical to drive the effective governance, implementation, and continuous improvement of global Quality Systems and Quality Risk Management processes
• Expert knowledge of FDA and EU GMP regulations, WHO GMP, ICH Q7, 9, 10 and EU Guidelines on Good Distribution Practice on Medicinal Products for Human Use.
• Familiar with device and combination product requirements as outlined in FDA 21 CFR Parts 4 and 820 and EU Medical Device Regulations.
• Demonstrated success supporting inspections and remediation programs.

Required Languages

Gross Annual Salary starting from: 80.000€
Please note: The salary indicated in this posting complies with local pay transparency regulations for Italian employment contracts. Final offers will be tailored to the successful candidate's experience, professional expertise, and interview journey, while ensuring internal equity. At Recordati, we are committed to a comprehensive, fair, and competitive remuneration system; a full overview of your total rewards package will be shared and discussed with you during the recruiting process.

At Recordati we believe in people! Inspired by our purpose - unlocking the full potential of life - we are committed to creating a diverse environment and cultivating a culture of inclusion. We strive to continually lead with our values and beliefs, enabling our employees to bring their whole selves to work and develop their potential.

We are proud to be an equal opportunity employer. We recruit, develop and reward without regard to, amongst others, gender, sexual orientation, gender identity or expression, national origin, age, physical or mental ability, race, ethnicity, political or religious belief.