Antonio De Melo Ferreira
Millsboro
Summary
Dynamic quality assurance leader with extensive experience at Bristol-Myers Squibb, driving regulatory compliance and enhancing internal controls. Proven track record in problem resolution and continuous improvement, achieving significant reductions in backlog and on-time delivery. Expert in policy administration and trend analysis, fostering high-performing teams to meet industry standards.
Overview
36
36
years of professional experience
Work History
Director, Validation, Product Development Quality
Bristol-Myers Squibb, Co.
New Brunswick
02.2008 - 12.2025
- Oversaw Quality Assurance for Commissioning, Qualification, Validation, and Change Management in Product Development Quality.
- Provided strategic leadership for compliance systems addressing Deviations, CAPAs, and Development Change Management.
- Developed and managed Quality Coach program focusing on Problem Solving and Decision Making for newly trained personnel.
- Led continuous improvement initiatives for Deviation and CAPA programs through regular coaching and feedback.
- Owned Product Development TrackWise system, managing administration, training, upgrades, and user access reviews.
- Presented quarterly compliance metrics to Quality Council and Executive Leadership Team for informed decision-making.
- Acted as subject matter expert on Deviation and CAPAs during regulatory inspections to ensure compliance.
- Served as Kaizen leader on continuous improvement projects within Research and Development.
Consultant, Quality Systems
Daiichi Sankyo Pharma development
Edison
12.2007 - 02.2008
- Consulted and supported the QA review and release of finished product. Reduced the backlog of finished product from 58 batches to 18 batches within 2 months.
- Provided consulting services for the TrackWise Investigational system and the Product Complaint program.
Manager, QA Contract Partners
Schering-Plough Corporation
Kenilworth
01.2006 - 12.2007
- Developed, implemented and managed a group providing QA oversight of 19 contract partners. Created and provided group vision, defined performance metrics and established group goals.
- Forged agreements with partners governing technical/quality criteria in compliance with GMP and legal policies. Documented related performance and presented metrics to Quality Council each month.
- Provided technical and quality advice on all investigations and validation issues related to company products. Monitored onsite validation processes and conducted quality visits to contract partners.
- Collaborated on process improvement initiatives with contract partners. Assisted with GMP audits and served on multiple development and commercialization teams for new products.
- Improved contract partner on-time commitment rates from 89% to 98% within one year.
- Key player in the approval of Claritin Reditabs (5mg) in the U.S.
- Participated in the approval and successful launch of Clarinex Reditabs and D12 within the EU.
- Recipient of multiple Shining Performance Recognition Awards.
QA Release Manager
Schering-Plough Corporation
Kenilworth
01.2004 - 12.2006
- Spearheaded a 12-member team engaged in the review and disposition of all finished products manufactured in NJ, 3rd party products for distribution by the company, active pharmaceutical ingredients, and incoming raw and packaging materials. Trained new staff and instituted key performance metrics.
- Participated in FDA and other regulatory agency inspections. Restructured team dynamics and eliminated slow moving inventory. Directed batch record flow and review process improvement projects.
- Improved on-time delivery from 51% to 99.1% within two years.
- Received several Shining Performance Recognition Awards.
QA Documentation Compliance Manager
Schering-Plough Corporation
Kenilworth
01.2002 - 12.2004
- Established a new QA documentation compliance group to provide final QA approval of validation and qualification protocols, summary reports, change control documents, variances, procedures, manufacturing orders and other production/quality documents. Trained and supervised 14 staff and consultants.
- Provided leadership and direction for successful completion of all validation commitments of the consent decree. Ensured that all related documents and procedures complied with GMP and company standards.
- Conceived and conveyed group vision. Participated in multiple FDA inspections, and served as QA representative to multiple review boards to ensure compliance and consistency throughout the company related to process, computer system and equipment validation.
- Led the successful completion of 100+ GMP significant steps of the consent decree.
- Reviewed and approved 15,000+ GMP documents for consent decree commitments.
- Received several Shining Performance Recognition Awards, and a Special Award Payment for selection as a critical manager for the company in 2004.
Supplier Quality Control Manager
Schering-Plough Corporation
Kenilworth
01.1997 - 02.2002
- Managed a staff of 23 employees performing the sampling/testing of all incoming components in NJ. Audited component suppliers, streamlined workflow and testing, and reorganized/upgraded the receiving, component testing, raw material sampling and filing storage areas.
- Reduced component testing turnaround time from 21 to 11 days.
- Implemented a tailgate sampling process with multiple component suppliers.
Analytical Testing Manager
Schering-Plough Corporation
Kenilworth
01.1996 - 12.1997
- Managed solid dosage testing groups within the analytical laboratory, and the related testing of finished products manufactured at the NJ facility. Managed a staff of 21 Chemists.
Analytical Testing Supervisor
Schering-Plough Corporation
Kenilworth
01.1995 - 12.1996
- Instituted and supervised a new instrumentation support group engaged in the validation, calibration and maintenance of all analytical instruments within the QC laboratories.
QC Project Team Leader
Schering-Plough Corporation
Kenilworth
01.1993 - 12.1995
- Supervised the construction of a $20M U-22 quality control laboratory. Coordinated all related scheduling, budgeting, workflow and critical systems validation processes.
- Completed construction three months ahead of schedule and under budget. The facility received the Laboratory of the Year Award by R&D Magazine in 1996.
Analytical Testing Supervisor
Schering-Plough Corporation
Kenilworth
01.1990 - 12.1993
- Managed the analysis and testing of solid dosage forms in support of manufacturing objectives. Supervised seven chemists.
Education
Kepner-Tregoe’s Program Leader Upgrade Training -
10.2013
Lean Sigma Kaizen Leader Training -
04.2011
Kepner-Tregoe Program Leader -
10.2008
Kepner-Tregoe Process Facilitation and Coaching -
10.2008
Kepner-Tregoe’s Problem Solving Decision Making Train the Trainer Workshop -
04.2008
Bachelor’s Degree - Chemistry
Rutgers University
01.1984
Adjunct Professorship - Regulation and Compliance in the Pharmaceutical Industry
Stevens Institute of Technology
Skills
- Regulatory compliance coordination
- Policy interpretation and administration
- Leadership in problem resolution
- Conflict management and resolution
- Internal control enhancement
- Industry standards maintenance
- Trend analysis in compliance issues
Languages
Spanish
Professional
Portuguese
Professional
References
References available upon request.
Timeline
Director, Validation, Product Development Quality
Bristol-Myers Squibb, Co.
02.2008 - 12.2025
Consultant, Quality Systems
Daiichi Sankyo Pharma development
12.2007 - 02.2008
Manager, QA Contract Partners
Schering-Plough Corporation
01.2006 - 12.2007
QA Release Manager
Schering-Plough Corporation
01.2004 - 12.2006
QA Documentation Compliance Manager
Schering-Plough Corporation
01.2002 - 12.2004
Supplier Quality Control Manager
Schering-Plough Corporation
01.1997 - 02.2002
Analytical Testing Manager
Schering-Plough Corporation
01.1996 - 12.1997
Analytical Testing Supervisor
Schering-Plough Corporation
01.1995 - 12.1996
QC Project Team Leader
Schering-Plough Corporation
01.1993 - 12.1995
Analytical Testing Supervisor
Schering-Plough Corporation
01.1990 - 12.1993
Kepner-Tregoe’s Program Leader Upgrade Training -
Lean Sigma Kaizen Leader Training -
Kepner-Tregoe Program Leader -
Kepner-Tregoe Process Facilitation and Coaching -
Kepner-Tregoe’s Problem Solving Decision Making Train the Trainer Workshop -
Bachelor’s Degree - Chemistry
Rutgers University
Adjunct Professorship - Regulation and Compliance in the Pharmaceutical Industry
Stevens Institute of Technology