Nancy M. Fahmy
Metuchen,NJ
Summary
Quality and Data Integrity professional with 9+ years of experience across pharmaceutical and biotech environments, including Novartis, Bristol Myers Squibb, and CytoSorbents. Proven expertise in data integrity strategy, risk management, regulatory compliance, and continuous improvement. Recognized for leading cross-functional initiatives, driving a culture of data integrity excellence, and delivering sustainable quality outcomes in GMP environments. Lean Six Sigma certified with a strong data-driven mindset and collaborative leadership approach.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Data Integrity Lead
Novartis Pharmaceuticals
11.2024 - Current
- Accountable and Responsible for all aspects for the Data Integrity program, including, creation, implementation, defining, monitoring and reporting KPIs, creating solution for KPI improvement and continuous improvement of the program
- Led data integrity initiatives to enhance accuracy across multiple platforms.
- Drove awareness and change management activities across the site to ensure a culture of Data Integrity Excellence.
- Proactively drove establishment of Data Integrity culture through implementation and monitoring of the Data Integrity program individually and through the network and global.
- Drove and monitored site progress against the Data Integrity plan, oversaw site implementation of corrective and preventative actions (CAPAs) associated with DO topics and related mitigation of risks.
- Drove continuous/sustainable improvement in detecting and mitigating DI risk by workings with SMEs to embed DI focus in existing site programs
- Collaborated with cross-functional teams to develop best practices for maintaining data integrity in the organization.
- Actively participated in process improvement initiatives aiming for Right First Time (RFT on documentation and deviation reduction in collaboration with process expert team.
Senior Specialist, QA Data Integrity
Bristol Myers Squibb
10.2023 - 11.2024
- Responsible for executing data integrity documentation periodic reviews and performing risk monitoring of implemented systems across all sites to ensure continued compliance.
- Responsible for assisting with the implementation of Global Data Integrity Processes at the site and ensuring that Global programs are implemented on-time.
- Assist in ensuring local site activities are harmonized with Global DG/DI standards.
- Provide feedback and support to GMP areas in scope during process improvement, while ensuring compliance with Global DG/DI policies and standards.
- Responsible for ensuring systems at Summit West, NJ CAR T facilities comply with data life cycle requirements from initial data creation/recording to archival and decommissioning. This includes, but is not limited to, data management (e.g., data creation, data processing, review, reporting), data security, data traceability, process mapping, data backup/restore, electronic signature/electronic record linking and data audit trails.
- Responsible for creating and executing data integrity assessments of new and existing systems including, but not limited to, manufacturing and laboratory systems to ensure compliance with regulatory requirements and company established requirements for data integrity.
- Drive mitigation and remediation when data integrity gaps are identified.
- Work with functional area SMEs at Summit West CAR T facility to ensure data risks are identified, remediated and prevented.
- Seek out and recommend to management opportunities for increased data integrity program efficiencies and operational improvement through modifications to current systems, implementation of new systems and more efficient use of established systems.
- Provide the GMP functions any updates regarding data integrity regulations that they may be impacted by.
Specialist, QA Data Integrity
Bristol Myers Squibb
03.2022 - 10.2023
- Responsible for executing Data Integrity Process/System risk assessments
- Responsible for updating Global DI Risk Register monthly
- Attend weekly project meetings
- Provide support Ad-hoc when needed
- Responsible for providing weekly Data Integrity new hire training
QA Analyst
CytoSorbents Inc.
01.2019 - 03.2022
- Responsible for reviewing executed batch records and released batch records
- Responsible for reviewing analytical test results and entered results into control charts
- Assisted in product release from Quality end
- Assigned deviation numbers and determined applicable closure requirement
- Responsible for monthly deviation meeting
- Assigned numbers to document change orders and reviewed any document change orders
- Created new SOP’s and revised existing SOP’s as applicable
- Assisted in internal and external audits
- Assisted in pre-audit walk through of the facility
- Interpreted and implemented quality assurance standards
- Responsible for CAPA team meeting with representatives from 5 departments, assigned CAPA numbers, made sure implementation was effective and closed out CAPA’s in a timely manner
QA Associate
CytoSorbents Inc.
01.2018 - 01.2019
- Responsible for reviewing executed batch records and released batch records
- Responsible for reviewing analytical test results and entered results into control charts
- Assisted in product release from Quality end
- Assigned deviation numbers and determined applicable closure requirement
- Responsible for monthly deviation meeting
- Assigned numbers to document change orders and reviewed any document change orders
- Created new SOP’s and revised existing SOP’s as applicable
- Interpreted and implemented quality assurance standards
QA Associate
Tulex Pharmaceuticals
05.2016 - 01.2018
- Assigned investigation, CAPA and change control numbers as requested and provided periodic status report to management of pending documents
- Reviewed executed batch records and released batch records
- Responsible for AQL inspections, releasing room/equipment during production
- Assigned code numbers for incoming material/in-process/finished product, received raw material, sampled raw material/ finished material, logged material to quality control lab
- Reviewed results of raw material/finished product prior to final approval
- Contacted suppliers, send them audit questionnaires and followed-up on reports
- Assisted in internal and in regulatory audits at the company and provided the necessary support
- Maintained stability program of drug products
- Oversaw the calibration/PM of process equipment and lab instruments
- Created any new SOP’s and revised the existing SOP’s as applicable and assisted to train on the document
Education
Master of Science - Pharmaceutical Engineering
New Jersey Institute of Technology
Bachelor of Science - Chemical Engineering
New Jersey Institute of Technology
Skills
- Teamwork and collaboration
- Problem-solving
- Time management
- Reliability
- Data-driven decision making
- Continuous improvement
Affiliations
- American Institute of Chemical Engineers (NJIT Chapter)
- National Society of Leadership and Success (NJIT Chapter)
- Society of Women Engineers (NJIT Chapter)
- Arab American Association Engineers & Architects (Sri-State Chapter)
Certification
Lean Six Sigma Verification Code: 60832687
Timeline
Data Integrity Lead
Novartis Pharmaceuticals
11.2024 - Current
Senior Specialist, QA Data Integrity
Bristol Myers Squibb
10.2023 - 11.2024
Specialist, QA Data Integrity
Bristol Myers Squibb
03.2022 - 10.2023
QA Analyst
CytoSorbents Inc.
01.2019 - 03.2022
QA Associate
CytoSorbents Inc.
01.2018 - 01.2019
QA Associate
Tulex Pharmaceuticals
05.2016 - 01.2018
Bachelor of Science - Chemical Engineering
New Jersey Institute of Technology
Master of Science - Pharmaceutical Engineering
New Jersey Institute of Technology