Michelle Aprelino Alito
The Hague
Summary
Experienced Qualified Person (QP) with a strong understanding of regulatory requirements and a track record of ensuring compliance within the GMP/GDP environment. Skilled in interpreting international, regional, and local regulations, and applying them effectively to the batch disposition process. Deep expertise in cell therapy, biologicals and pharma processes, technology, and commercialization. Collaborative and proactive in working with global, site, and vendor oversight Quality and Supply Chain functions to ensure efficient and compliant batch disposition. Adept at managing quality and compliance risks through thorough risk assessments and mitigation actions. Proficient in conducting final reviews and approvals of non-routine quality investigations, identifying product and process quality improvements, and maintaining a robust quality management system. Strong communication and negotiation skills. Experienced as a lead auditor. Committed to personal development in an inclusive environment.
Overview
23
23
years of professional experience
Work History
Associate Director Quality Systems EU Qualified Person
BMS Netherlands Operations
04.2022 - Current
- Qualified Person as per requirements of the Manufacturing License and execute functions in accordance with Professional Code of Conduct
- Qualified Person duties as defined in article 51 of 2001/83/EC, Annex 16 and the ATMP guidelines of Volume 4 of the EU GMP guidelines
- Interpretation of international, regional, and local regulations and apply those regulations within the GMP/GDP environment and the batch disposition process in the EU
- Responsible to build up a deep knowledge of the processes, technology and the specific treatments which are intended to be commercialized
- Routine interactions with global, site, and vendor oversight Quality and Supply Chain functions to ensure a compliant, efficient, and timely batch disposition
- Active member of GMP- or GDP-related health authority inspections as required, responsible to respond to any noted observations, and ensure implementation of corrective actions
- Management of quality and compliance risks by conducting risk assessments and ensuring risk mitigation actions are taken
- Responsible for final review and approval of non-routine quality investigations related to batch deviations, batch disposition, and other quality systems for assigned products as required
- Identify and recommend product and process quality improvements
- Author of procedures, work instructions, and Standards, as required
- Draft or review, negotiate with contractors, and recommend approval for Quality Agreements
- Managed cross-functional teams for multiple large-scale projects, successfully completing each on time and within budget constraints.
- Established strong relationships with key industry partners, creating mutually beneficial opportunities for growth and collaboration.
- Implemented data-driven decision-making strategies, leading to more informed business choices and positive outcomes.
Senior Quality Assurance manager - EU Qualified Person
Celgene Distributions B.V.
04.2019 - 03.2022
- Development and continuous improvement of quality systems and processes related to oversight and QP release of Commercial Products
- Align with internal and external contacts involved in manufacture and supply of Commercial Products (quality, supply, CMO QPs)
- Commercial Qualified Person per requirements of the manufacturing license and in accordance with the Professional Code of Conduct
- Fulfill Qualified Person duties as defined in article 51 of 2001/83/EC
- Ensure continued compliance, operationally, to site manufacturing license
- Interpret international, regional, and local regulations and apply those regulations within the GMP/GDP environment
- Interact with executive level employees at third party contractors
- Interact with Corporate and International functions as required by the tasks and responsibilities
- Provide advice and guidance regarding GMP and Qualified Person requirements within the EU supporting and advising teams involved in manufacture and supply of commercial products including supply management, QA, regulatory
- Manage quality and compliance risks by conducting risk assessments and ensuring risk mitigation actions are taken
- Identify and recommend product and process quality improvements
- Support the contractor audit program
- Support in establishing technical/quality agreements
- Conduct internal and contractor audits
- Support external GMP/GDP site inspections, as required
- Maintain compliance with personal training requirements
- Review and approve/reject batch records, both master production/packaging records and executed batch records of assigned contractors
- Disposition (release/withhold) drug product/substance batches of assigned products for distribution (or further processing) to each specific country/region of the world
- Act as Member of Recall Committee as required
- Review, edit, negotiate improvements to, and approve contractor documentation, including investigations, change controls, OOSs/Excursions
- Ensure logs, databases, and files related to the product quality activities are maintained
- Collaborated with cross-functional teams to ensure seamless integration of quality assurance measures throughout the development lifecycle
- Mentored junior team members, fostering a culture of continuous learning and professional development within the department
- Adapted quickly to changing priorities and market demands, ensuring timely delivery of high-quality products under tight deadlines
- Streamlined QA processes for increased efficiency, resulting in faster release times
Quality Assurance Manager
DSM-Sinochem Pharmaceuticals (current name Centrient Pharmaceuticals)
01.2016 - 01.2019
- Lead auditor for external and internal audits
- Responsible Person deputy
- CMO qualification and oversight
- Documentation and archiving team leader
- Quality Assurance Systems compliance and continuous improvement at the CMO: Change Controls, Deviations, CAPAs, Complaints handling and investigations; validations and PQR's
- Verification of CoA and CoC from CMO's
- Batch records review and approval for compliance with regulatory dossiers
- Qualified trainer
- Creation and implementation of the internal Quality Assurance Systems: writer, reviewer, and approver of Good Manufacturing Practices documentation
- Preparation of Quality Agreements with contracted companies as well as with customers as appropriate
- Providing support for Pharmacovigilance system
- Single point of contact for customers related to quality topics.
Quality Assurance Specialist- Governance and Escalation
GlaxoSmithKline Biologics
01.2014 - 01.2016
- Effectiveness analysis and measurement of existing processes within Quality Governance
- Identify, lead and mentor improvement opportunities for Quality Escalation in 17 GMP manufacturing units
- Part of the decision team to review Policies & Processes applied through all sites
- Manage events, CAPAs, and change controls related to the QMS and escalations
- Assist in internal audits as a SME (Subject Matter Expert) and a co-auditor
- Scribe during regulatory authorities' inspections (FDA and ANVISA)
- SOP author and trainer
- Ensure adequacy of KPIs to monitor the Quality Escalation System
- Act as SME for the Quality Escalation process
- Communicate with stakeholders, internal and external
- Ensure critical topics are adequately and promptly escalated to higher management
- Real-time documentation of the Belgium Quality Council meetings.
Quality Assurance Officer
Janssen Vaccines And Prevention
01.2013 - 01.2014
- CMO qualification and oversight
- Certified Auditor Sterile Products Manufacture by NSF Health Sciences
- Review and approval of the Master Production Records and test instructions, In Process Controls, Batch Production Records and test results, documentation related to technology transfer of clinical processes, batch-related non-conformities investigations, CAPA's, and change controls
- Preparation of release of clinical batches
- Participate and assist in regulatory audits and agency inspections, project team meetings, and training activities
- Maintain and update quality agreements with CMOs
- QA duties related to Product Complaints, investigations, and escalations
- QA representative in CMC meetings.
Quality Assurance Technician in the Poliomyelitis vaccine drug substance production
GlaxoSmithKline Biologics
01.2011 - 01.2013
- Daily oversight on the shopfloor of aseptic zones and aseptic manufacturing
- Qualified for entering Class B area
- Verification of the SOPs' compliance on the field
- Ensure traceability of raw-material
- Release of sterile gowning and radiated equipment
- Work side-by-side with operators
- Take samples for the protocols and swab after line clearance and disinfection; approval of the line clearance
- Follow-up of CAPA's
- Reconcile the validation protocols and the processes
- Review of GMP documentation: batch records, autoclaves' cycles, stove cycles, and radiation of material, deviations, and CAPA's
- Prepare documentation for batch release
Quality Assurance Carrefour Supermarket
Belgium
01.2008 - 01.2011
- Food Quality Assurance for the Catering department at 'Carrefour supermarket chain'
- Ensure good hygiene practices during production - HACCP
- Suppliers' audit
- Coordinate and participate in sensory testing
- Participate in project meetings with buyers and suppliers
- Participate during internal audits, HACCP Monitoring
- Request and follow up on product enhancements
- Organize packaging information according to the directives
- Work with the IT department to assure specification tool validated
- Complaints management and follow-up (corrective actions)
- Assistance during crisis management.
Nights and weekend shifts Laboratory Technician
Institut Jules Bordet, Cancer Specialized Hospital
01.2001 - 01.2008
- Calibration of machines, blood analysis, and results reporting.
Education
Master of Science - Medicinal Chemistry
Milton Keynes Open University
UK12.2018
Skills
- Process Improvement
- Strategic leadership
- Crisis Management
- Analytical Thinking
- Decision-Making
- Onboarding and training
- Coaching and Mentoring
- Critical Thinking
- Regulatory Compliance
- Systems Development
E Mail
Michelle.alito@hotmail.com
Professional Mailing Address And Country
Orteliuslaam 1000, Utrecht, BD, 3528, The Netherlands
Current Position
04/01/22, Associate Director Quality Systems EU Qualified Person for ATMPs, BMS Netherlands Operations, N
Educational History( May Include Academic And/Or Professional Qualifications)
- QMS QP role, October-2022, NSF UK
- Conference on ATMPs, June-2022, PDA/ Belgium
- Dutch language courses A1 - B1, MAR-2022, ABCDutch (online)
- Conference on ATMPs, 23-24-JUN-2020, PDA/ Belgium (online)
- ATMPs, 24-NOV & 04DEC 2020, NSF / UK
- ATMPs, 15-17 SEP-2020, NSF / UK
- Drug Development from Quality by Design to Clinical Studies, 1-3 SEP-2020, PAOFarmacie / Netherlands
- Quality Management: Role of the QP, NOV-2020, PAOFarmacie / Netherlands
- Quality and safety for the manufacturing of biopharmaceuticals, DEC-2020, PAOFarmacie / Netherlands
- Ambient transport and cold chain- Temperature controlled transports of medicinal products, OCT-2019, ECA / Berlin / DE
- GMP for Biological and Biotechnology products, JUL-2019, NSF Health Sciences / Stockley Park / UK
- Aseptic Manufacturing Using and Automatic Filling Line, JUL-2019, Biotech Training Facility / Leiden / NL
- Master of Science degree in Medicinal Chemistry, DEC-2018, Open University Milton Keynes / UK
- Communication with Power and Impact, OCT-2017, Rotterdam School of Management, Erasmus University of Executive Education/ NL
- Good Distribution Practices/ Responsible Person, DEC-2016, Pharmatech / NL
- How to audit - Sterile Products Manufacture, APR-2014, NSF Health Sciences / UK
- Bachelor of Science degree in Nutrition, SEP-2007, Institut Arthur Haulot/ BE
Languages
Portuguese
Native language
English
Proficient
C2
French
Proficient
C2
Dutch
Intermediate
B1
Timeline
Associate Director Quality Systems EU Qualified Person
BMS Netherlands Operations
04.2022 - Current
Senior Quality Assurance manager - EU Qualified Person
Celgene Distributions B.V.
04.2019 - 03.2022
Quality Assurance Manager
DSM-Sinochem Pharmaceuticals (current name Centrient Pharmaceuticals)
01.2016 - 01.2019
Quality Assurance Specialist- Governance and Escalation
GlaxoSmithKline Biologics
01.2014 - 01.2016
Quality Assurance Officer
Janssen Vaccines And Prevention
01.2013 - 01.2014
Quality Assurance Technician in the Poliomyelitis vaccine drug substance production
GlaxoSmithKline Biologics
01.2011 - 01.2013
Quality Assurance Carrefour Supermarket
Belgium
01.2008 - 01.2011
Nights and weekend shifts Laboratory Technician
Institut Jules Bordet, Cancer Specialized Hospital
01.2001 - 01.2008
Master of Science - Medicinal Chemistry
Milton Keynes Open University
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