Saema Saiyed
Dallas,Texas
Summary
Dynamic Senior Manager with extensive experience at Sobi AB, excelling in supplier quality and compliance. Proven track record in implementing EQMS systems and driving continuous improvement initiatives. Adept at managing cross-functional teams and fostering strong supplier relationships, ensuring adherence to regulatory standards while enhancing operational efficiency. Strong analytical and leadership skills.
Overview
13
13
years of professional experience
Work History
Senior Manager, Supplier Quality Clinical Operations
Sobi AB Global Quality
Durham, USA
04.2023 - Current
- Acted as a central point of contact for managing Inquiries, Investigations, Change Controls, CAPAs and Audit Observations between External Manufacturers and Internal Stakeholders for IMP suppliers
- Oversaw Batch Record Review of IMP products for Clinical Trials in the US, EU, and ROW regions, ensuring Compliance with Global Standards and GCP
- Managed Supplier Relationships with CRO by ensuring adherence to Quality Agreements and Collaborated on Risk Mitigation Strategies with internal teams
- Played a key role in supporting CRO/CMO Audits and Evaluations, ensuring alignment with regulatory requirements for Clinical Batches
- Developed and tracked KPIs for Operational Quality Assurance Activities, ensuring Continuous Improvement and alignment with Business Goals
- Worked closely with Qualified Persons (QP) to ensure seamless release of IMP lots per the dossier(IMPD)
- Partnered with CRO and internal regulatory team in managing and tracking substantial and non-substantial Changes associated with IMPD dossier
- Collaborated with Clinical Trial Managers and Clinical Supplier Managers to ensure uninterrupted supply of the IMP to the sites/patients is achieved by addressing any quality issues
- Provided QA expertise in writing and execution of the Clinical Trial Protocols (Phase 1 to 4)
- Formulation expertise: Sterile/Biologics, Small molecule Solid Oral Dosage
Manager, External Manufacturing Quality Assurance
Bausch Health Companies
Bridgewater, USA
04.2021 - 03.2023
- Oversaw the Quality Assurance activities of the Contract Manufacturers (CMOs), mitigated risks and ensured Compliance with GMP Standards
- Acted as an SME for the small molecules API/Drug Product and Finished Goods manufacturing, Testing and Packaging
- Executed the evaluation and approval of product/process/system Changes, managed Non- conformances, CAPA plans, and Customer Complaint
- Tracked and trended Quality data and presented Quality Improvement plans to the CMO during quarterly Business Review Meetings
- Laid out QA expectations in the designing of user interface during the implementation of SAP system for Batch Record Review
- Executed Test Script Runs, Validation and Implemented SAP system for Batch Review/Returns and Rework modules
- Managed site's Change Management Program in Trackwise system along with notable improvements
- Successfully migrated open records between two systems and reduced the Change Control backlog by 50% within three months
- Timely completion of monthly KPI to identify and rectify trends associated with Quality data
Manager, Quality Assurance
Bausch Health Companies
Manitoba, Canada
08.2020 - 03.2021
- Managed a team of 10 direct and indirect reports, providing leadership in the deployment of quality systems including Deviations, Change Controls, Complaints, Batch Review and Document Management
- Ensured site Audit readiness for Regulatory Inspections (FDA, Health Canada, UI, ANVISA) by maintaining high compliance standards
- Reviewed and approved the Process Validation and Stability reports
- Deployed an improved techniques of Batch Record Review and reduced the cycle time by 60%
- Developed and implemented Total Quality Management and Quality by Design principles across the site to drive consistent quality improvements
- Partnered with Regulatory team in implementation of critical Change Controls and follow- up with regulatory agencies
- Implemented RASCI chart and robust SOPs to reduce the Change Control backlog by 40%
- Managed and reviewed key Quality Performance Indicators (QPIs)to ensure alignment with business and regulatory goals
Supervisor, QA and Regulatory Documentation
Bausch Health Companies
Manitoba, Canada
10.2016 - 07.2020
- Assessed site change controls for regulatory impact and ensured compliance
- Monitored impact of changing regulations on submission strategies
- Prepared and coordinated regulatory submissions
- Participated in risk benefit analysis for regulatory compliance
- Assisted the team in the development of regulatory strategy
- Executed Drug Establishment Registration and listing (Foreign NDC) to FDA
- Document control including document review, approval, archiving and tracking
- Provided leadership oversight in management and destruction of GMP records
- Implemented lean principles and Kaizen activity
- Development of new procedures (SOPs) and policies
- Employee development, Conflict Management, Time Management activities
Quality Compliance Group Leader
The Nature’s Bounty Company-NBTY
Manitoba, Canada
04.2014 - 10.2016
- Directed CAPA system management, root cause analysis, and non-conformance investigations, ensuring timely resolution of quality issues.
- Led the preparation of annual product quality reviews and trending analysis to identify areas for improvement.
- Managed vendor qualification processes, including Quality Agreement reviews and re-assessments.
- Prepared post audit responses and monthly updates to the regulatory agency on license conditions
- Created Policies and Procedures on Quality management systems
- Managed master validation documents and monthly PM records of the packaging equipment
Laboratory Coordinator
The Nature’s Bounty Company-NBTY
Manitoba, Canada
05.2013 - 04.2014
- Assisted in testing raw materials and finished products, ensuring compliance with compendial standards
- Managed vendor classifications and calibration verification of equipment, supporting quality assurance functions
- Collaborated with the Analysts and Third-Party Laboratories on the method transfer projects
Research Associate
Red River College
Manitoba, Canada
09.2012 - 04.2013
- Developed and Executed the process of Canine Plasma Protein Purification by downstream processing using an Ion exchange chromatography technique, optimized yield and ensured compliance with pharmacological study protocols.
Education
EQi Certification (EI Advantage) -
Winnipeg, MB10.2018
Project Management -
Red River College
Winnipeg, MB10.2017
French Language Level 1 -
University of St. Boniface
Winnipeg, MB01.2016
Pharmaceutical Manufacturing Certificate -
Red River College
Winnipeg, MB04.2013
Bachelor of Pharmacy (B. Pharm.) -
Gujarat Technological University
India06.2012
Skills
- EQMS systems: Trackwise, SAP, M2M, Veeva, Doc Space (D2)
- Document management: Compliance Wire eDMS, SOP Online
- Office software: Microsoft Office Suite
- Regulatory compliance: FDA, EMEA, Health Canada, ANVISA, HC, UI
- Lean and Six Sigma: Process and continuous improvement
Accomplishments
- Regulatory Success: Led successful FDA, Health Canada, and EMEA audits with no critical findings across multiple sites.
- Process Improvement: Spearheaded initiatives that reduced non-conformance rates by 20% through enhanced supplier quality management.
- Leadership: Built and led cross-functional teams, improving collaboration between internal and external stakeholders in clinical operations.
Timeline
Senior Manager, Supplier Quality Clinical Operations
Sobi AB Global Quality
04.2023 - Current
Manager, External Manufacturing Quality Assurance
Bausch Health Companies
04.2021 - 03.2023
Manager, Quality Assurance
Bausch Health Companies
08.2020 - 03.2021
Supervisor, QA and Regulatory Documentation
Bausch Health Companies
10.2016 - 07.2020
Quality Compliance Group Leader
The Nature’s Bounty Company-NBTY
04.2014 - 10.2016
Laboratory Coordinator
The Nature’s Bounty Company-NBTY
05.2013 - 04.2014
Research Associate
Red River College
09.2012 - 04.2013
EQi Certification (EI Advantage) -
Project Management -
Red River College
French Language Level 1 -
University of St. Boniface
Pharmaceutical Manufacturing Certificate -
Red River College
Bachelor of Pharmacy (B. Pharm.) -
Gujarat Technological University
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