Joseph Zicarelli
Nazareth
Summary
Highly motivated individual with ten (10) years of Manufacturing experience and seventeen (17) years of Quality Assurance experience in licensed manufacturing environments. In addition, one (1) year of Regulatory Affairs experience. Other professional experience includes: Strong management experience. Extensive experience with Regulatory Agency Inspections. Manage teams in defense of various programs and processes during these inspections. This includes, but not limited to, direct interaction with FDA, TGA, PMDA, ANSM, MHRA, GCC, Health Canada, Mexico Ministry of Health, Boards of Pharmacy, DEA, and Customer Audits. Areas of expertise include Quality Assurance, Bulk Formulation, 503B Compounding, Filling, Inspection, Labeling & Packaging, Viral Concentrate Manufacturing, Bacterial Product Manufacturing, Sterility Assurance and Aseptic Processing. Experience working with Trackwise, eDoc, Documentum, Geode, SAP, ISOtrain, GRIDS (Veeva Vault), Master Control. Extensive experience managing several Quality Systems, including Change Controls, CAPAs, Deviations, Customer Complaint Investigations, SOP’s, Batch Records, and Internal Audits. Proven leadership abilities with a strong focus on cultivating a quality-driven culture within teams. Experience with Bacterial and Viral Vaccine Product Lines.
Overview
26
26
years of professional experience
Work History
Director, Quality Assurance – Site Quality Head
Quva Pharma
Bloomsbury
04.2024 - Current
- Overseeing all Site Quality operations, supporting formulation, compounding, inspection, labeling, and packaging processes
- Manage Lot Disposition, Sterility Assurance, Maintenance/Metrology, and Quality Systems
- Leading a team of 125+ Quality Assurance professionals, including Associate Directors, Managers, Supervisors, and Technicians, ensuring the effective execution of key quality deliverables
- Directing the review and final approval of deviation investigations, change controls, CAPAs, shop floor quality engagement/auditing, routine environmental/system monitoring, procedures, and batch records
- Driving site-critical quality decisions, collaborating with the Texas counterpart site and C-Suite leadership on key quality issues, risk mitigation strategies, and remediation efforts
- Serving as the site lead during regulatory inspections, defending site programs and activities
- Providing strategic direction for quality and compliance, implementing inspection readiness programs and developing site initiatives aligned with evolving regulatory expectations
- Managing and enhancing Quality Systems to ensure compliance, efficiency, and continuous improvement in site quality operations
- Serving as a key member of the Site Leadership Team, contributing to overall site strategy and operational excellence
Associate Director, Regulatory Affairs - Biosimilars
Teva Pharmaceuticals
West Chester
04.2023 - 04.2024
- Supporting the Global Regulatory Lead (GRL) in strategic vision and regulatory leadership in defining the global regulatory strategy for biosimilar (BioS) projects
- Leading and/or supporting the Global Regulatory Affairs (GRA) Team for assigned projects to ensure alignment of the regional, clinical and Chemistry Manufacturing and Controls (CMC) regulatory strategies with the overall global strategy
- Assisting other GRLs in ensuring collaboration with key internal stakeholders of the Core Project Team (CPT), Clinical Development Team (CDT), and CMC Team to ensure successful planning and execution of the global regulatory strategy for assigned projects
- Planning and execution of successful global regulatory strategies, submissions and approvals for assigned biosimilar project(s)
- Delivering successful regulatory license applications and product life cycle management submissions with the Global Regulatory Affairs Team from initial filing through post-approval management
- Supporting the regional strategic leads on the establishment and maintenance of high quality working relationships with the FDA, EMA, PMDA and other global regulatory agencies as appropriate for assigned products
- Managing direct reports to ensure successful planning and execution of the global regulatory strategy for assigned projects
Director, Quality Assurance - Formulation, Filling, Inspection and Packaging
Sanofi Pasteur
Swiftwater
01.2020 - 04.2023
- Managing the Quality Assurance support of all formulation, filling, inspection, labeling and packaging areas
- Also included is oversight of batch release, product quality and material release, maintenance, metrology, and quality systems
- Leading a staff (35+) of Quality Assurance Deputy Directors, Managers and Technicians in the routine execution of key deliverables including the review and final approval of deviation investigations, change controls, CAPAs, Shop Floor Quality engagement/auditing, Routine environmental/system monitoring, procedures, and batch records
- Execution of site-critical quality decisions
- Interface with site and global senior leadership on critical issues in providing quality input and decisions as well as proposed remediation or risk mitigation strategies
- Serving as a site lead in defense of various site programs and activities during regulatory body inspections
- Providing strategic direction for the site on matters that pertain to quality and compliance
- This includes execution of inspection readiness programs throughout the year and development of site programs that aligned with evolving site and regulatory expectations
- Serving as a member of the Site Quality Leadership Team and Site Quality Council
Director, Quality Assurance - Antigen, Quality Control, Stability, Maintenance and Sterility Assurance
Sanofi Pasteur
Swiftwater
09.2017 - 01.2020
- Managing the Quality Assurance support of all antigen manufacturing areas (viral, bacterial, seed, and biological service areas), Sterility Assurance, Quality Control, and Maintenance
- Leading a staff of Quality Assurance Deputy Directors and Managers in the routine execution of key deliverables including the review and final approval of deviation investigations, change controls, CAPAs, shop-floor auditing, procedures, and batch records
- Execution of site-critical quality decisions
- Interface with site and global senior leadership on critical issues in providing quality input and decisions as well as proposed remediation or risk mitigation strategies
- Serving as a site lead in defense of various site programs and activities during regulatory body inspections
- Providing strategic direction for the site on matters that pertain to quality and compliance
- This includes execution of inspection readiness programs throughout the year and development of site programs that aligned with evolving site and regulatory expectations
Deputy Director, Quality Assurance - Formulation, Filling, Inspection and Packaging
Sanofi Pasteur
Swiftwater
06.2014 - 09.2017
- Managing a team of Quality Assurance managers in providing direct compliance oversight of the critical aseptic formulation, filling, inspection, labeling and packaging areas
- Also included is oversight of batch release, product quality and material release, maintenance, metrology, and quality systems
- Assuring that all products meet safety, efficacy, potency, and purity in accordance with all regulatory requirements in facilities that consist of bulk formulation, filling, inspection, labeling, packaging, and aseptic processing
- Reducing the quality and compliance risk for these manufacturing areas
- Representing the organization during regulatory agency inspections
- This includes acting as an inspection table lead and providing facility tours for agency inspectors as well as defending product disposition decisions within deviation investigations
- Managing Quality Assurance compliance activities relating to cGMP auditing, the change control system, CAPA system, and the deviation investigation system
- This includes providing the final Quality review for these systems as well as driving improved deviation, CAPA, and change control closure rates across the manufacturing areas
- Supporting various project teams that include facility start-up, new product implementation, facility and process improvement, personnel development, and quality mindset
- Approving new positions and interviewing candidates applying for positions within Quality Assurance
- Directly supporting critical business objectives
Senior Compliance Manager, Quality Assurance
Sanofi Pasteur
Swiftwater
05.2008 - 06.2014
- Assuring that all products meet safety, efficacy, potency, and purity in accordance with all regulatory requirements in facilities that consist of viral concentrate manufacturing, bulk formulation, filling, inspection, labeling & packaging, and aseptic processing as Senior Compliance Manager
- Managing a five-member team responsible for compliance in formulation, filling, inspection, labeling & packaging, and distribution
- Managing teams responsible for FDA and EU inspections, including Pre-Approval Inspections for new manufacturing facilities, as well as annual and bi-annual inspections
- Responsible for managing teams in defense of various programs and processes during these inspections
- This includes direct interaction with FDA, TGA, PMDA, Health Canada, and Mexico Ministry of Health
- Conducting interviews for candidates applying for positions within Quality Assurance
- Participating (2011) in International FDA inspection
- Providing daily shop floor coverage to ensure cGMP compliance with established policies, procedures, and cGMPs
- Performing audits to facilities, processes, and systems
- Serving as Quality Assurance representative/lead on multiple project teams
- Reviewing and approving standard operating procedures, standard work instructions, master specifications, batch production records, and batch filling records
- Reviewing, assessing, and approving corrective and preventative actions, change controls, and deviations to ensure compliance with established policies and procedures as defined by the company and other regulatory/government bodies
- Managing teams responsible for internal inspections, including Global Corporate Quality and Parexel
- Communicating and interacting on daily basis with Operations, Quality Control, Validation, Engineering, Regulatory Affairs, Maintenance, Metrology, and Safety
Manager, Quality Projects, Qualification and Validation
Sanofi Pasteur
Swiftwater
02.2007 - 05.2008
- Serving as Quality Representative on project teams for new formulation, filling, and influenza manufacturing facilities
- Reviewing and approving qualification/validation protocols, data packs, and reports to ensure compliance with established policies and procedures as defined by the company and other regulatory/government bodies
- Serving as Quality Representative on project team for new vaccine
- Reviewing and approving standard operating procedures, standard work instructions, change controls and deviations
- Reviewing and approving documents related to the new facilities including, factory acceptance test protocols, functional requirement specifications, detail design specifications, site acceptance test protocols, validation protocols, and associated reports
- Participating in FDA and EU inspections
- Serving as Quality Representative on factory acceptance tests for equipment in new manufacturing facilities
Manager, Manufacturing Technologies
Sanofi Pasteur
Swiftwater
05.2002 - 02.2007
- Leading team on design, factory acceptance tests, site acceptance tests, commissioning, qualification, and start-up of a new Formulation and Filling facility
- Identifying, reviewing, and approving engineering modifications
- Serving as Task Force Leader for formulation, buffer, and equipment turnover in new Formulation and Filling facility
- Leading Influenza Task Force team to develop process improvements
- Leading resolutions in quality, personnel, and scheduling issues
- Reviewing, approving, and authoring SOPs, SWIs, Process Descriptions, P&IDs, IQ/OQ/PQ Protocols, IQ/OQ/PQ Data Packs and reports, Experimental Protocols, and Change Controls
- Managing non-exempt employees and conducting performance reviews, set objectives, created development plans and goals with personnel, placing recommendations and approving promotions/merit increases for personnel, resolving personnel conflicts, and conducting interviews/hiring new employees
- Training Operations personnel and team members in processes and procedures
- Communicating and operating with Operations, Quality Assurance, Quality Control, Validation, Engineering, Regulatory Affairs, Maintenance, and Safety
- Liaising with outside vendors, contractors, and consultants
- Coordinating schedules to meet project needs
- Leading Pharmaceutical Technology for new products in Phase II and Phase III clinical trials
Supervisor, Bulk Manufacturing
Wyeth-Lederle Vaccines (Division of American Home Products)
Pearl River
07.2001 - 05.2002
- Supervising production of Aluminum Phosphate Suspension, an intermediate for production of Prevnar Vaccine
- Coordinating aluminum operations to ensure compliance with current SOPs, cGMPs, and market inventory demands
- Revising / Writing SOPs, Manufacturing Investigation Reports (MIRs), and batch records
- Managing bulk manufacturing operators
- Conducting performance reviews, setting objectives, creating development plans and goals with personnel, resolving personnel conflicts, and conducting interviews/hiring new employees
- Leading resolutions in manufacturing quality, personnel, and scheduling issues
- Training bulk manufacturing operators in processes and procedures
- Executing final review for batch records before auditing by Quality Assurance
- Communicating and operating with Quality Assurance, Quality Control, Technical Services, Maintenance, and Safety
- Liaising with outside vendors, contractors, and consultants
- Maintaining inventory of raw materials and purchased equipment and supplies to meet production schedule
- Collaborating in opening new facility for increased production of Pnu-Imune Vaccine, which involved coordinating with Engineering and Validation departments, as well as conducting Factory Acceptance Test in Switzerland
- Appointing member of team found to initiate most efficient and compliant means for product and material transport throughout plant site
Production Biologist, Bulk Manufacturing
Wyeth-Lederle Vaccines (Division of American Home Products)
Pearl River
03.1999 - 07.2001
- Leading production technician in the manufacture and sterile filtration of HibTITER and Pnu-Imune vaccines
- Performing environmental monitoring and prepared equipment/glassware
- Gaining certification in gowning and aseptic operations covering Class 100 to Class 100,000 areas
- Coordinating and maintaining production schedule in accordance with material management and market demands
- Maintaining inventory of raw materials, equipment, and supplies to meet production schedule
- Revising / Writing SOPs, Manufacturing Investigation Reports (MIRs), and batch records
- Training new personnel
- Communicating and operating with Quality Assurance, Quality Control, Technical Services, Maintenance, Safety, outside vendors, contractors, and consultants
Education
Bachelor of Science Degree - Biology
Alvernia University
Reading, PA05.1997
Skills
- Quality management
- Deviation management
- Change control
- CAPA management
- Inspection readiness
- Team leadership
- Risk mitigation
- Stakeholder engagement
- Process improvement
- Root cause analysis
- Effective communication
Timeline
Director, Quality Assurance – Site Quality Head
Quva Pharma
04.2024 - Current
Associate Director, Regulatory Affairs - Biosimilars
Teva Pharmaceuticals
04.2023 - 04.2024
Director, Quality Assurance - Formulation, Filling, Inspection and Packaging
Sanofi Pasteur
01.2020 - 04.2023
Director, Quality Assurance - Antigen, Quality Control, Stability, Maintenance and Sterility Assurance
Sanofi Pasteur
09.2017 - 01.2020
Deputy Director, Quality Assurance - Formulation, Filling, Inspection and Packaging
Sanofi Pasteur
06.2014 - 09.2017
Senior Compliance Manager, Quality Assurance
Sanofi Pasteur
05.2008 - 06.2014
Manager, Quality Projects, Qualification and Validation
Sanofi Pasteur
02.2007 - 05.2008
Manager, Manufacturing Technologies
Sanofi Pasteur
05.2002 - 02.2007
Supervisor, Bulk Manufacturing
Wyeth-Lederle Vaccines (Division of American Home Products)
07.2001 - 05.2002
Production Biologist, Bulk Manufacturing
Wyeth-Lederle Vaccines (Division of American Home Products)
03.1999 - 07.2001
Bachelor of Science Degree - Biology
Alvernia University