The Context

A renowned and historic production company in the pharmaceutical sector, known for its diversified product range and commitment to the highest international quality standards, is currently seeking a Quality Director & QP. This pivotal role will help navigate the company through a significant transition period.

The Role
We are looking for an exceptional candidate to take on the dual responsibilities of Qualified Person and Quality Director (QC and QA), overseeing a substantial team of direct and indirect reports. Key responsibilities include:

• Regulatory Compliance: Ensuring full adherence to legal requirements for the Qualified Person in interactions with local and European Authorities.
• Batch Release: Guaranteeing that each batch is analyzed and released for market distribution in compliance with GMP and relevant legal standards in Italy and destination countries. Ensuring the production facility maintains its manufacturing authorization and operates within regulatory guidelines.
• Development Support: Deciding on the introduction of new products and technologies, ensuring regulatory compliance, securing necessary authorizations, and adhering to legal provisions.
• Quality Control: Overseeing quality controls, chemical, and physicochemical analyses of finished products, raw materials, and packaging, as well as microbiological analyses in compliance with GMP standards. Supporting all validation activities.
• Stability Studies: Managing stability studies and documentation according to current regulations and ICH guidelines.
• Quality System Management: Leading the Quality System area with a team dedicated to the documentation and procedural aspects of Quality.

• Educational Background: Degree in pharmaceutical chemistry and technology, pharmacy, chemistry, industrial chemistry, biological sciences, medicine and surgery, or veterinary medicine.
• Professional Credentials: Licensed to practice and registered with the professional board.
• Language Skills: Advanced English proficiency (minimum level B2).
• Regulatory Knowledge: Deep understanding of GMP and industry regulations.
• Process Expertise: Extensive knowledge of internal and general production processes.
• Quality Systems: Thorough familiarity with the company's quality system and current procedures.
• Technical Skills: Proficiency in office and specialized departmental software.
• Safety Standards: Knowledge of laboratory safety regulations.
• Leadership and Collaboration: Strong decision-making, leadership, and team development skills.
• Problem Solving: Effective problem-solving abilities.
• Negotiation Skills: Proven negotiation capabilities.
• Strategic Vision: Ability to plan and maintain a comprehensive vision.
• Confidentiality: Commitment to maintaining confidentiality.

This is a unique opportunity to play a critical role in a prestigious company during a key phase of its growth and transformation. If you possess the expertise and drive to excel in this role, we would love to hear from you.

• Talent Acquisition & Employer Branding: Attracting top talent and enhancing the company's employer brand to secure a competitive advantage.
• Training and Development: Designing and implementing comprehensive training programs and career development paths to foster employee growth and engagement.
• Labor Relations: Managing labor relations and union negotiations, ensuring a balanced and harmonious workplace environment.
• Personnel Cost Management & KPI Analysis: Monitoring and optimizing personnel costs while conducting in-depth KPI analysis to support strategic decisions.
• Organizational Design & Change Management: Actively participating in organizational design and leading change management initiatives to support the company's evolving needs.

• Dynamic Environment: Be part of a fast-growing and internationally recognized company with a strong commitment to innovation and excellence.
• Challenging and Rewarding Role: Engage in diverse HR functions and have a significant impact on the company’s success.
• Global Exposure: Collaborate closely with Corporate HQ and regional teams, offering opportunities for global interaction and career advancement.
• Supportive Culture: Work in a supportive environment that values resilience and adaptability, essential traits for navigating the company’s evolving landscape.

• A degree in Law or Economics.
• Significant experience in industrial or manufacturing environments.
• Fluent English, essential for interactions with the HQ and for pursuing advanced career opportunities.
• Strong problem-solving skills with the ability to anticipate challenges.
• Excellent organizational and communication skills.
• Familiarity with technological platforms and advanced systems.
• Resilience and adaptability, with the capability to thrive in a high-stress environment and handle complex organizational changes.

• Condurre un'analisi approfondita delle prestazioni effettive delle vendite, inclusi ricavi, margini e redditività per prodotto, regione e cliente
• Individuare opportunità di ottimizzazione delle vendite, riduzione dei costi e miglioramento dell'efficienza
• Gestire Net e Gross Sales
• Valutare l'impatto di nuove strategie di pricing e promozioni, per massimizzare i ricavi e la redditività delle vendite
• Rivedere regolarmente il margine di contribuzione per prodotto e raccomandare adeguamenti per migliorare la redditività, senza compromettere i volumi di vendita
• Gestire il datawarehouse con l'obiettivo di garantire l'integrità dei dati e la conformità alle esigenze aziendali
• Partecipare al processo di S&OP
• Sviluppare previsioni di vendita basate sugli esiti del processo S&OP in termini di volumi di vendita a livello di singolo prodotto.

• Laurea in Economia o Finanza
• Esperienza pregressa di almeno 5 anni in un ruolo analogo in aziende produttive
• Esperienza in contesti strutturati e di stampo internazionale
• Conoscenza di SAP
• Forte spirito di collaborazione
• Approccio proattivo e finalizzato al miglioramento dei processi
• Ottima conoscenza della lingua inglese

• Collects local requirements and reports them to Global contacts for implementation.
• Provides consultancy and promotes digitalization and automation projects in the production field.
• Develops and supports the development of applications such as MES and production planning.
• Acts as project manager where required or provides support to projects.
• Acts as the point of contact for the development of local applications – (collects new requirements, supports the business in testing and acceptance phases, coordinates/maintains systems by interfacing, where possible, with external suppliers or colleagues in support).
• Promotes the use of applications by supporting users in training and testing phases of any new functionalities.
• Analyzes various business processes, identifying areas for improvement and optimizations that can also be supported by new technologies.
• Supports local users in utilizing corporate IT tools provided by the group.

• 5 years of experience in production environments (either through consulting/system integrator firms or within IT departments). Experience in automation projects and technological implementations.
• Good knowledge of SAP R/3 or SAP S/4HANA modules PP/MM or experience in migrating from SAP ECC to S/4.
• Proficiency in written and spoken English; knowledge of other languages will be considered a plus.
• Effective Communication
• Leadership and Influence
• Change Management
• Problem Solving and Critical Thinking
• Resilience and Stress Management
• Collaboration and Teamwork
• Goal Orientation
• Negotiation Skills