Head of Quality Systems and Risk Management at Recordati S.p.A

Recordati S.p.A; Milano; Ibrido; EUR 80.000 - 100.000; Tempo pieno

Descrizione del lavoro

Recordati S.p.A in Milano seeks Head of Quality Systems and Risk Management to lead global QMS and QRM across GMP manufacturing, laboratories, supply chain, distribution operations, contract partners and affiliates. You will act as corporate process owner for quality systems, ensuring compliance, inspection readiness, patient safety, product quality and continuous improvement across the organization.

Fluent in English; Bachelor degree in a related field and 12–15 years of pharma quality

Competenze

• Bachelor degree required in pharma, chemistry, engineering, microbiology or related field.
• Experience with QMS governance and quality systems.
• 12–15 years of progressive pharmaceutical quality experience.

Mansioni

• Govern global Quality Management System and ensure effectiveness of its quality elements.
• Drive quality metrics, analytics and system trending.
• Establish standards for APR/PQR processes.
• Lead enterprise Data Integrity strategy and oversight.
• Govern Supplier Quality requirements and performance monitoring.
• Lead inspection readiness programs and support health authority inspections.
• Establish global risk-based auditing program.
• Support acquisitions, integrations and global harmonization programs.

Conoscenze

QMS governance

Risk management

Regulatory compliance

Cross-functional leadership

Data-driven decisions

Quality culture transformation

Formazione

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

Descrizione del lavoro

Head of Quality Systems and Risk Management at Recordati S.p.A in Milano, LOM, IT. This Full time on site position offers great opportunities for career growth. Head of Quality Systems and Risk Management ID: 2839 Date of Posting: Sep 25, 2026 Business Area: Quality Job Type: Direct Employee On site / Remote / Hybrid: Hybrid Hub Office: Milano, IT 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.
• Establish standards for APR/PQR processes.
• 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.

Technical Competencies

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

Fluent in English

Salary

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.