Diego Bochicchio

CURRICULUM VITAE  

Diego Bochicchio

Via Calabria, 17

00187 – Rome, Italy

Phone +39 0636006063 (home), Mobile +39 3476137042

diego.bochicchio@gmail.com

Age: 53

Status: Married (3 sons)

EXECUTIVE SUMMARY:

26+ years spent in the Pharmaceutical Industry primarily in Quality Operations. First-class master degree cum laude in Pharmaceutical Chemistry (CTF) and honors degree as a Pharmacist. Qualified Person (QP) and Senior International Auditor since 2003. Hands-on approach with a “can do” attitude.

Senior expertise in Pharmaceuticals and Medical Devices GMPs and Manufacturing (including Aseptic Operations), Quality Compliance, Quality Systems, Warehouse and Distribution (GDPs), Business Development.

A Professional with a keen interest in the Quality and Business Development areas for Pharmaceuticals, Medical Devices, Healthcare and other industrial entities; highly pragmatic, change-oriented, and open to different company cultures. Professor (contracted) at University of Rome ‘Tor Vergata’ for Pharmaceuticals and Medical Devices business and quality operations.

Present: Director, Quality Compliance & Regulatory EU, QP, Principal Consultant.

Past:Senior Consultant at Pfizer (Validant), CQA Senior Manager Southern Europe Cluster (Italy, Greece, Spain, Portugal, Malta, Cyprus) at Baxter. Italy Country/Market Manager for a German international company producing flexible packaging for the Pharmaceutical and the Medical Device Industries (Bischof + Klein). Quality/GMP Lead Auditor and Primary Quality Consultant. Manager and Lead Assessor of Quality Systems within the manufacturing of APIs, Sterile and Non Sterile Drug Products, Medical Devices, Tobacco Products, and Cosmetics products. Assessor and consultant of certified companies for ISO 9001, ISO 13485, ISO 22716, and ISO 15378 Quality Systems.

Skills:Quality Management, Quality Auditing, Quality Compliance, Business Strategy and Development, Business Management, Project Management, Negotiation, Innovation, Coaching, Spin Off, Integration, Due Diligence.

KPI’s:

- FDA Remediation Plan Workstream Leader, Quality Leader Advisor

- Management of 20 HCs Team.

- Southern Europe Functional Leader: 1. Baxter Biosciences business spin-off (Baxalta) 2. Gambro QMS Integration into Baxter QMS.

- 20 Regulatory Audits passed (EMA, AIFA, FDA, other Agencies): 9 FDA, 11 AIFA (Italian MoH), 15 Customers Quality Audits managed (GSK, Boehringer Ing., Sandoz, Elan, others).

- Approximately 120 Supplier Quality Audits performed within Europe between 1996 and 2014.

- Approximately 30 Quality Systems Audits and Gap Assessments performed as Principal Consultant.

- 4 Big-Pharma Companies supported in the GMP/Quality Systems improvement (J&J, Pfizer, Baxter, Cargill).

- 3.2 Mln € of sales developed in 8 years at B+K. 400k€ developed and managed at CAI in 2018-2020.

CAI, Commissioning Agents Incorporated

Director GMP, Quality Compliance & Regulatory EU, QP, Principal Consultant

Date: August 2018 - present

Selected Accomplishments:

- Develop and support the South EU market strategy in line with the EU strategies.

- Organize meetings and promote the business at Clients’ VP, GM, and Senior Director level

- Monitor business KPI and react with corrective actions as necessary.

- Conducting and leading Quality, Regulatory, and Commissioning Projects activities;

- Act as Quality Point of Contact for Clients Projects.

- Developed and responsible for the local QMS at CAI Italy.

- SME for Quality Risk Management, FDA-readiness, Data Integrity and ISO 13485 Certification projects;

CURRICULUM VITAE

- Development of documentation (e.g. Remediation Plans, Technical Reports, QRM documentation, Quality Agreements, Client Policies and SOPs, other);

- Execution of Quality Compliance and/or Quality System Design activities;

- Manage CAI Teams when requested being also responsible of P&L (Profits and Losses) of the related Work Orders;

- Management of any aspect relevant to Quality and Regulatory as requested such as Change Control, Quality Oversight, Quality System, Audit, Contractors and Vendors Quality Management, Documentation Control, External QP activities, others;

- Keeping up to date with current regulatory, PDA and ISPE documents as required or as designed by Client Manager or Business Area Lead.

- Provide assistance and guidance to staff to ensure KPIs and management reporting are achieved.

-  Interact to assist EU senior management in promoting effective collaboration with global functions.

University of Rome ‘Tor Vergata’ - Pharmacy

Professor (contracted)

Date: February 2021 - present

Periodic lectures and seminars on the pharmaceuticals and medical devices business and quality operations.

PAST EXPERIENCES:

1. Pfizer, Catania (Italy)

Senior Consultant, Quality Manager (Validant)

Date: May 2016 – August 2018

Sterile Lyophilized Dosage Forms

Selected Accomplishments:

- Senior Quality point of contact for the Site Leadership Team.

- Act as Quality Point of Contact for Engineering Projects.

- Provide Quality Leader advisory.

- Provide guidance in the interpretation of quality guidelines and assist in the development of strategies for achieving/maintaining high levels of compliance.

- Assist Pfizer in the preparation and handling of Health Authorities inspections.

- Investigations Project Team Leader from August 2016 to November 2016 (coordinating 10 investigation leads)

- Provide advice and counsel on the development, implementation and maintenance of the Site Quality System

in close collaboration with Pfizer Corporate Quality Management.

- Manage QRM global programs at site level.

2. Baxter, Italy

South Europe CQA Senior Manager (Italy, Greece, Iberia, Malta, Cyprus)

Date: September 2014-April 2016

Selected Achievements and Main Tasks:

- Cluster Head of QA. Total of 18 professionals with 4 direct reports at Managerial Level.

- Quality Management of key projects (Baxalta Spin Off, Gambro QMS Integration).

- Supply Chain Quality Compliance

- QP Release

- Suppliers Management and corrective actions (SCAR)

- Post Marketing Surveillance (Complaints, FCA, MDR, QDR, FAR),

- Quality Systems Management (CAPA, Internal & External Audit, Distributors and 3rd Party Logistics).

- Ensures that appropriate contacts with Business Functions (General Manager, Sales, Marketing, W&D, Supply Chain, Technical Services, Regulatory Affairs, Pharmavigilance) are maintained as profitable (about 700Mln$ turn-over).

- Leads the Italian Quality Council (8 QPs Attendees).

CURRICULUM VITAE

3. GMP-Innovation Consulting

Partner, Senior Quality/GMP Consultant, Qualified Person

Date: 2011-2014

GMP-Innovation, a Consulting Association performing GMP Gap Assessments, Risk Management Processes, Computerized Systems Validation, Regulatory Inspection Readiness programs, Quality Audits, Trainings and other planned activities for Pharmaceuticals, Biotechnologies, Medical Devices and Cosmetics Firms Quality Systems (Italian and/or International, www.gmp-innovation.com).

Selected Achievements and Main Tasks:

- 1 FDA Inspection passed with no 483 report (J&J, 2013).

- 8 Customer GMP Inspections passed with only some minor issue (Pharma Trade, 2013).

- Full Implementation of a Country Quality System (Vifor Pharma, 2013).

- Supports European and Global teams for marketing strategies implementation

- Negotiates and achieves contracts

- Establishes business plans at short and medium term (5 years)

- Budget control

- Sales monitoring and metrics

- Senior Management Advanced GMP Trainings (Cargill, 2010; Scandolara Group, 2012; Segena, 2013).

- 1 AIFA Inspection Readiness Program (Cargill, 2011).

- Qualified Persons Personal Advisor.

- Audits to Key Suppliers (APIs, Contractors, Raw Materials) on behalf of International Companies.

- Strategies for Quality Assurance Units and Middle-Management Quality Coaching.

- GDPs Assessments and QA Supply Chain Advisor.

- Development and implementation of Site Master Files.

- Site GMP Gap and Compliance Assessments.

- Quality Site Assessments for Cosmetics (ISO 22716) and Medical Devices (ISO 13485 products) Companies.

- Contract Quality Agreements.

- Process, Cleaning, Equipment and IT Validation Assessments.

4. Bischof und Klein GmbH (B+K)

CleanFlex® Market Manager, Italy

Date: June 2006-August 2014

Business development and market consolidation for Sterile Flexible Packaging in the Pharmaceutical Industry, Medical Devices, Cosmetics, Fine Chemicals, other categories: 3,2 Mln€ of turn-over developed.

Reports to: Global Marketing & Sales Director

Selected Responsibilities:

- Country sales budget goals achievement

- Develops strategies agreed with the German headquarter

- Develops and implements marketing strategies

- Develops new business in Italy through a wide network in the Pharmaceutical industry

- Develops new projects and products in contact with the R&D dept.

- Establishes partnerships with industrial partners

- Collects information on competitors

5. Pfizer, Italy

Position: Quality Assurance Systems, Latina Plant

Date: 2000-2006

Product Categories: Bulk APIs, OTCs, Sterile/Non sterile Pharmaceuticals, Sterile/Non sterile Animal Health, Qualified Person (Back-up)

- Execution of Corporate Audits to Key Suppliers (APIs, Contractors, Raw Materials) on behalf of Pfizer Inc,

USA. Setting goals and management strategies for the Quality Assurance Systems Unit.

CURRICULUM VITAE

- Successfully passing 5 AIFA and 1 EMEA GMP inspections.

- Coordinating a team of skilled people to assure the site GMP Compliance, the internal/external auditing programs and the Supplier Compliance.

- Development and implementation of Pfizer Quality Standards guidelines (Corporate Quality Policies).

- Establishing a plan for managing the internal auditing activities by coaching 15 persons from Production, Engineering, Logistics, QC, etc. in the manufacturing site.

- Executing GMP Trainings.

- Development and implementation of the Site Master File.

- Completion of a Site GMP Gap Assessment on approx. 80 different finished products processes (together with DBA-NSF Senior Consultants).

- Compliance activities for new raw materials and packaging components (sterile and non-sterile).

- Site implementation of a TrackWise® system for the Audit Action Items and CAPAs tracking.

- Customized Quality Assessments for Contractors on GMPs of cosmetics (ISO 22716) and medical device (ISO 13485 products).

- Change Control Management.

- Problem solving for GMP/QA compliance issues.

- Quality Unit budget preparation.

- Quality Metrics development and monitoring.

- Liaising with Site Compliance/RA Managers providing adequate support for routine registration activities.

- GMP Trends Analysis implementation and periodic evaluation.

6. Bristol-Myers Squibb, Italy

Position: Quality Assurance/Vendor Control, Latina and Anagni Plants

Date: 1995-2000

Product Categories: OTC, Sterile/Non sterile Pharmaceuticals (oncologicals, beta-lactams), APIs Bulk

Production

- Validation Management (Process, Cleaning) for Sterile and Non Sterile Manufacturing Processes.

- Team Member for 6 FDA and 3 MoH inspections successfully passing.

- Coordination of the Internal and External Quality Audit Programs.

- QA Support for the Supply Chain development in the Italian sites.

- Quality Management of Purchasing Specification, Batch Release, Under Test Shipments, Reworks, Returns

and Destruction of obsolete materials.

- Preparation of Technical and Regulatory Controlled Documents.

- Providing QA support in writing Technology Transfer protocols.

- Development of Quality Metrics.

- Quality Management of Batch Release, Returns, Recalls, Reworks, Manufacturing Instructions and SOPs

approval.

- Production/Technical Staff Training.

- Process and Cleaning Validation (Drug Products).

- SAP R/4 Implementation Team (QA).

- Support RA, QC, Purchasing, Production, Logistics, and other departments to provide information for the

regulatory registration documentation.

- Support the Regional QA in order to define and implement Best Practices.

- Master Batch Records, QC Specification, Bill of Materials control and approval.

- IQ/OQ/PQ Protocols development.

 6a. BMS Anagni Site - QA Supervisor (Feb 1998 - Jun 1999)

- Manage a team of 5 QA HC’s

- Oversight on Batch Release processes

- Assure the site GMP Compliance, the internal/external auditing programs and the Supplier Compliance.

- Execute GMP Trainings.

- Change Control Management.

- Problem solving for GMP/QA compliance issues.

CURRICULUM VITAE

- Quality Unit Budget preparation.

- Quality Metrics development and monitoring.

- GMP Trends Analysis implementation and periodic evaluation.

- Validation Management (Process, Cleaning) for Sterile and Non Sterile Manufacturing Processes.

- Preparation of Technical and Regulatory Controlled Documents.

- Master Batch Records, QC Specification, Bill of Materials control and approval.

- IQ/OQ/PQ Protocols development and conduction.

REFERENCES:  Letters available upon request.

LANGUAGES:  Italian (Mother language),Fluent English.  

EDUCATION:

1st Bachelor Degree (110/110cum laude), Chemistry and Pharmaceuticals Technology – University of Rome, 1993. 2nd Bachelor Degree (110/110), Pharmacy – University of Rome, 1995.

CONTINUOUS EDUCATION:

Leadership Development (1998, M&D Management & Development), Negotiate to Win (1999, Global Strategic Sourcing BMS), Purchasing Strategies (1999, Global Strategic Sourcing BMS), Leadership (2001, Pfizer Human Resources Headquarter), Coaching (2002, Pfizer Human Resources Headquarter), Public Speaking (2002, Pfizer Human Resources Headquarter), Stress Management (2002, Pfizer Human Resources Headquarter), Quality Systems ISO 9001 (2004, UNI ISO/AMGQ, Italy), Applied Quality Systems (2005, PDA-KMI Parexel), High

Containment Systems (2007, GEA Niro), Executive Coaching (HayGroup, 2007), Marketing (Tesi, 2008), Strategic Marketing (Tesi, 2009), Innovation Management. (Logotel, 2009), Client Coaching (Logotel, 2009), The Financial Statements Audit (CFMT, 2009), Medical Devices ISO 13485:2003 and 21 CFR Part 820 (GMP-Innovation, 2011), Cosmetics GMPs ISO 22716:2008 (GMP-Innovation, 2011), GAMP5 Implementation (ISPE, 2011). AFI QP’s Membership with Conferences, Baseline Guide Vol 5 (ISPE), ASTM E-2500 (CAI), Events and Trainings active participation, Advanced Project Management Training (CAI).