Enrica Picardi

· Partner with other functional leaders (e.g. across the Execution Leadership Team - XLT) and Site General Managers to develop and maintain a meaningful and robust Patient First and Quality culture across all aspects of the business.

· Through clear and visible advocacy, champion Catalent’s Quality Management system (QMS), and ensure strong technical and leadership capability at all levels of the Quality organization.

• Work with Site Quality Directors and General Managers to translate and operationalize Quality, Regulatory and Compliance strategy is a way that is appropriate for individual sites while maintaining a robust “One Catalent” QMS.
• Responsible for ensuring the site Quality leadership teams are staffed with high caliber Quality leaders and professionals, driving strong and effective performance culture at all levels and across the sites.
• Ensure appropriate metrics and reporting / escalation processes are in place, and being utilized to drive and improve required operational execution & performance levels, and drive appropriate corrective action planning when needed.
• Demonstrate strong business and fiduciary responsibility in the management of their budget, and broader business decision-making; acting as both a functional and business leader.
• Develop strong customer relationships, partnering with other Catalent leaders to establish outstanding performance and customer impact that acts as a true competitive differentiator.

During this period assigned to a project to support FDA 483 remediation for the Brussels site:

• establish and coordinate a task force to respond to FDA PAAL and execute full CAPA plan accordingly
• define and led mfg operations restart after relevant remediation
• led the quality organization ensuring appropriate leadership and key roles to be filled in
• prepare the site for the FDA PAI audit
• support FDA audit in august 2022, resulting in VAI as for Nov 2023

• Demonstrated proficient leadership skills to motivate employees and build competent teams.
• Hired and managed employees to maximize productivity while training staff on best practices and protocols.
• Identified opportunities to improve business process flows and productivity.
• Collaborated with senior management to develop strategic initiatives and long term goals.

• Hired and managed employees to maximize productivity while training staff on best practices and protocols.
• Spearheaded cross-functional initiatives across departments to achieve business goals for bottom-line profits.
• Aligned organizational objectives with company mission to increase business growth and integrate work strategies.
• Resolved issues and recommended actions based on production and compliance reports.

• Budget and base cost management for all department
• People management and development
• All the processes performed in chemical and biological laboratories : i.e. chemical and biological analysis on API, raw materials, packaging materials, finished goods and semi finished goods, environmental and utilities controls
• Quality interface to customers mainly managing quality topics for all the 3 line of business (Pharmaceuticals, Cosmetic and Nutritionals)
• Quality systems strategy set up, definition and continuous improvements for all the 3 lines of business (LOB)
• All the processes in Quality assurance/QC area: i.e. GMP and regulatory compliance, batch release, investigations (deviations, complaints…), recall and market actions, Annual Product Review, training, change control, Regulatory agencies inspections, Supplier audit and customer audit, Quality Agreements, products testing and releasing, stability study and analytical method development
• Regulatory strategy and consulting for all the 3 LOBs
• New product development and introduction process (avg of 50 New Product launches per year); development revenue bdg and forecasting process
• Project management and quotation process coordination
• Reformulations and formulas adaptation where/when needed
• Proactive projects: from proof of concept till commercial phase
• New technology evaluation, scientific finalization and implementation
• Scientific support to customers (i.e. innovation forum); products troubleshooting resolutions
• Customer interactions and management on new product introduction project
• Monitored and coordinated workflows to optimize resources.

• Worked closely with organizational leadership and board of directors to guide operational strategy.
• Oversaw operations and provided corrective feedback to achieve daily and long-term goals.
• Monitored office workflow and administrative processes to keep operations running smoothly.
• Monitored and coordinated workflows to optimize resources.
• Budget management for all department
• People management and development
• All the processes performed in chemical and biological laboratories : i.e. chemical and biological analysis on API, raw materials, packaging materials, finished goods and semi finished goods, environmental and utilities controls
• Quality interface to customers mainly managing quality topics for all the 3 line of business (Pharmaceuticals, Cosmetic and Nutritionals)
• Quality systems strategy set up, definition and continuous improvements for all the 3 lines of business (LOB)
• All the processes in Quality assurance/QC area: i.e. GMP and regulatory compliance, batch release, investigations (deviations, complaints…), recall and market actions, Annual Product Review, training, change control, Regulatory agencies inspections, Supplier audit and customer audit, Quality Agreements, products testing and releasing, stability study and analytical method development
• Regulatory strategy and consulting for all the 3 LOBs

• Led a team of quality professionals (62 , with 4-5 direct reports), ensuring consistent adherence to company standards and regulatory requirements.
• · Budget management for all QO department
• · People management and development
• · All the processes performed in chemical and biological laboratories : i.e. chemical and biological analysis on API, raw materials, packaging materials, finished goods and semi finished goods, environmental and utilities controls
• · Quality interface to clients mainly managing quality topics; quality agreements; audits and regulatory topics as a third party
• · All the processes in Quality assurance area: i.e. GMP and regulatory compliance, batch release, investigations (deviations, complaints…), recall and market actions, Annual Product Review, training, change control, Regulatory agencies inspections, Supplier audit and customer audit, Quality Agreements

• Led a team of 63 quality professionals (having 5 direct report), having a dual reporting to the Site Leader and the Quality Operations Regional Leader. She is a member of the Site Leadership Team.

• Budget management for all QO department
• People management and development
• All the processes performed in chemical and biological laboratories : i.e. chemical and biological analysis on API, raw materials, packaging materials, finished goods and semi finished goods
• All the processes in Quality assurance area: i.e. GMP and regulatory compliance, batch release, investigations (deviations, complaints…), recall and market actions, Annual Product Review, training, change control, MoH and Corporate Inspections.

• Lead a group of 26 people in the Quality Operations department whose main task is to manage quality systems.
• Assessed product quality by monitoring quality assurance metrics, reports and dashboards.
• Conducted process and system audits to identify areas of improvement and enforce compliance with industry standards.
• Release of active principle, raw materials, finished products and packaging materials

• Performed root cause analysis to identify and resolve quality issues and defects , using right first time methodology
• Recall management, market withdrawals and stop distribution
• Packaging and Manufacturing In Process Control through the IPC auditors group
• Conducted risk assessments to identify and mitigate potential quality issues. Trend analysis and evaluation of deviation, complaints, RFT index
• Annual Product review
• Conduct self inspections and supplier’s inspections and qualification
• Standard Operating Procedures and GMP training
• Change control management, stability program
• Manage MoH and Coorporate inspections and relevant documentation (i.e. inspection reports, corrective and preventive action plans)
• GMP master documents management (including GMP computerized system)
• Support and define required validation and qualification efforts
• Policy and procedures able to grant compliance with the current national regulations and with the GMP

• Responsible of a group of 17 people in the Quality Operations department whose main task is to ensure the quality of products and manufacturing processes
• Release of active principle, raw materials, finished products and packaging materials
• Deviation management, root cause anlysis using Right First Time methodology
• Complaints management and Complaint Team Leader. All the complaints management and evaluation is based on right first time approach
• Recall management, market withdrawals and stop distribution
• Packaging and Manufacturing In Process Control through the IPC auditors group
• Trend anlaysis and evaluation of deviation, complaints, RFT index
• Annual Product review
• Policy and procedures able to grant compliance with the current national regulations and with the GMP
• Define and monitor quality metrics

• Responsible of finished products release in the Quality Operations department. Experiences developed in:
• Sterile and Non-sterile finished products release
• Deviations/complaints/ recall management
• Incoming materials release (packaging and raw materials)
• Quality metrics preparation

• Reporting directly to the Technical Director, team leader of a cross functional team in charge of all plant activities linked to the validation.
  In 2000 she created the Validation Section managing directly 4 people, defining role and responsibilities
• Equipment and systems qualification
• Sterile and Non-sterile production processes validation
• Cleaning and Sterilizing In Place processes validation
• Computer system validation in a project named CIMEX concerned about the Oral Solid Production Computerized Integration, working together with Kemper & Masterson Inc consultants
• Validation activities coordination in a project of sterile productions transfer from other plants. (Smithe Kline Beecham products to Pfizer)
• Planning, organization and management of validation documentation
• Technology Transfer process involvement, in collaboration with foreign colleagues. In this process she coordinates all the project activities inside the plant and was in contact with Pfizer Global Manufacturing Service
• Short time experiences in coordination and management of different production department
• Planning, participation and management of Ministry and Corporate inspections and audit. Since 1999 she was the back-room coordinator during all the inspections and participate actively through the entire inspection process
• Project Management

Grant winner in the National Research Program for Chemical matter Theme 13:

“Chemical products and technologies for the re-establishment of the stone and metallic materials.”

During this period she has matured the following experiences:

• Chemical Department of the University of Sassari, Prof. S. Russo Laboratory: Research in the field of aromatic polyammides synthesis and characterization study of the bootstrap model effect in the radicalic co-polymerization.
• Managerial and technical training at FORMIT foundation in Brindisi on the following subjects:
• Information Technology technical matters (personal computing, data bank, telecommunication)
• Introduction to the business system and its relations with the economic, political, social and both national and European scientific system
• Project Management (pert chart, scheduling and monitoring of timeline and milestones)
• Company laws and royalties
• Actions, both national and European, supporting industrial research
• Training course at the International University of Arts in Florence: work of arts history and technique, problems related to the restoration of work.