Luigi De Rosa

About Me

Biotechnologist with multidisciplinary expertise, enthusiastic and passionate about Pharmaceutical Quality Assurance.
Achieved considerable pharmaceutical experience in quality related activities for ensuring the compliance with relevant cGMP and regulatory requirements of all the aspects of the handling, manufacturing and distribution of pharmaceutical products and API working within multinational corporations as a primary quality contact with worldwide-based Contract Manufacturing Organizations and suppliers.
Very competent at handling multiple tasks, assigning priorities and controlling multiple projects and resources simultaneously under tight deadlines.
Strong analytical and problem solving skills. Action oriented, forward looking and a quick and intuitive thinker. Member of Mensa (the high IQ society)
Experienced in working within multicultural environments in different parts of the world, with colleagues having different experiences and professional needs.
Excellent communication, interpersonal, collaboration and negotiation skills.

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Experiences

Direct management and coordination of a team of four senior Quality Managers.
Accountable for providing Quality Oversight over External Entities (EE) manufacturing, testing, packaging, storage, and distribution sterile and non-sterile pharmaceutical products.
Responsible for all the activities at the External Entity (EE) sites associated with the Quality Operations for Organon products, to assure conformance to all applicable regulatory requirements, regulatory filings and company policies.
Providing support to build effective quality systems and drive continuous improvement activities at the EP. This includes participating in end-to-end risk management and strategic initiatives related to compliant supply, operationalizing quality, and developing an engaged and capable workforce within the extended external manufacturing organization

Responsible for the implementation of Quality Operations (Quality Assurance and Quality Control) policies and discharge all QO responsibilities supporting external parties/partners and alliances (EP’s) for manufacture, testing, packaging, storage, and distribution of sterile pharmaceutical products, API intermediates, API, non-sterile pharmaceutical products, biologics, drug delivery devices and consumer care products.
Assuring that products are produced from approved processes in conformance to all applicable regulatory requirements and Company policies and release of all manufactured products.
Exercising a leadership role in monitoring and maintaining the EP’s compliance with the FDC Act, Current Good Manufacturing Practices Regulations (domestic and foreign), and other pertinent legal requirements.
Ensuring the quality performance of EP’s through direct oversight, support and technical advice, counselling to the EP site senior leadership and providing on-site supervision. Including overseeing activities such as EP selection, GMP Due Diligence, and establishing Quality Agreements.
Providing support to build effective quality systems and drive continuous improvement activities at the EP. This includes participating in end to end risk management and strategic initiatives related to compliant supply, operationalizing quality and developing an engaged and capable workforce within the extended external manufacturing organization.

Managing the relationship with assigned suppliers in EU and Asia from a Quality perspective to ensure that all aspects of the products comply with the requirements of the GSK Quality Manual and meet relevant cGMP regulatory and legislative requirements, through defined key performance and quality indicators.
Accountable for establishing and maintaining an effective working relationship with the key contacts at each of the assigned suppliers. These include key contacts with Quality, Regulatory, Business Development, Production, Site Management and others.
Developing and maintaining, in partner with the Supplier Relation Manager (SRM), an effective working relationship with internal stakeholders and all members of the Supplier Relation Team.
Responsible for assessing the risk, identifying gaps and implementing quality action plans at assigned suppliers and communicating to the organization so the risks are proactively addressed.
Ensuring timely communication of Quality Alert issues. Co-ordinating and track any remediation deemed necessary.
Providing support to procurement throughout the supplier selection process.
Evaluating effectiveness of the suppliers’ Quality Unit and systems and influencing External Suppliers promoting robust systems under self-sufficient organizations.
Ensuring that investigations associated with assigned Suppliers are properly carried out, resulting in sustainable CAPA, documented, evaluated, and closed as efficiently as possible, and in respect with the procedure.

Primary point of contact for all Quality Related Items/Issues with Manufacturing Sites and Aspen Affiliates worldwide (deviations, OOS/OOE, complaints, CAPA, recalls, counterfeits and product tampering, stability failures, etc.).
Assessed manufacturing and quality documents such as Quality/Technical agreements and
stability and validation protocols.
Coordinated quality aspects of product technical transfers and other technical projects ensuring their compliant implementation.
Developed and enhanced working practices and processes within the Quality Assurance department, other streams (Supply Chain and Logistics, Regulatory, Packaging, Commercial Services), affiliates, external customers (distributors) and manufacturing sites.
Conducted internal audits on QA and other departments for ensuring compliance and improving systems and procedures.
Provided training to QA and cross-functional teams about continuous improvement, root cause analysis, quality management tools, change control management, GDP and GMP compliance.
Supervised and coached junior colleagues, monitoring workload and completion of activities.

Acted as Single Point of Contact (SPOC) for all quality related activities at the Third Party Suppliers, ensuring that all aspects of the handling, manufacturing and distribution of pharmaceutical products were in compliance with relevant cGMP, regulatory requirements, the Novartis Quality Manual and the effective Quality Agreements.
Managed all the critical quality issues (deviations, OOS/OOE, complaints, CAPA, recalls, counterfeits and product tampering, stability failures, etc.) according to the Quality Agreement and the Novartis Quality Manual, verifying the correct execution of investigations.
Ensured the correct management of Change requests, from receipt through to the implementation and closure.
Critically assessed the performance of products and processes and implemented Quality Risk Management.
Developed Supplier Quality Assurance Agreements.
Assessed and reviewed PQR/APR and Stability reports.

Achieved Good Manufacturing Practices (GMP) compliance activities for Active Pharmaceutical Ingredients (API) and food products: change control, deviations, review of deviation investigation reports.
Issued Master Batch Records and reviewed manufacturing batch records.
Delivered and reviewed quality system procedures and SOPs, GMP documents, specifications and analytical methods for raw materials, finished and intermediate products.
Executed Self-Inspections Audits.
Provided active support for FDA Regulatory Inspections. Audit passed with no 483.

I founded my own consultancy company and established collaborations with a network of professionals.
Implemented quality, environment and safety management systems for manufacturing and service companies.
Coordinated the suppliers’ validation team for qualification activities, inspection audits, implementation of product specifications and improvement plans.
Executed both internal and external audits of management systems for different types of companies.
Assured the compliance with applicable regulations and the relations with the inspection bodies.

Molecular characterization of bacterial communities involved in the Toscano cigar fermentation.
Design, management and execution of research projects particularly in the field of molecular biology and microbiology.

Skills

Quality Project Management

Advanced
GMP

Expert
Intuitive and critical thinking

Expert
Quality Assurance

Expert
Problem solving

Expert
Quality Auditing

Advanced
Root Cause Analysis

Expert
Open Minded

Expert
Result Oriented

Advanced
Continuous Improvement

Good

Italian

Expert
English

Expert
French

Good
German

Notions

Education

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Associate Director External Quality

Associate Director, External Site Quality Lead, Sterile Formulation

Associate Director External Quality

CMO Quality Manager API

Senior Quality Assurance Associate

Quality Assurance Specialist TPO Europe

Quality Assurance

Consultant for Quality, Environment and Food Safety MS

Researcher

Areas of Expertise

Languages

Master's Degree in Industrial and Bio Molecular Biotechnologies

Università Degli Studi Di NAPOLI "Federico II"

Master's Degree in Industrial Biotechnologies

Università Degli Studi Di NAPOLI Federico II

certification