MAJOBA GARDIZI
Sacramento,CA
Summary
Quality Assurance Manager with 20 years of experience in the pharmaceutical sector, specializing in manufacturing and quality process enhancement. Proficient in root cause analysis and change management, leading to substantial operational improvements. Recognized for high productivity and effective task execution, with a focus on quality system optimization and risk assessment to maintain product integrity. Committed to problem-solving and driving team success through operational excellence.
Overview
25
25
years of professional experience
Work History
Quality Assurance Manager
External Quality Vector CMO
06.2022 - Current
- Act as a quality expert for vector Manufacturing and supporting two different contract manufacturing facilities
- Conduct thorough reviews of batch records, change requests, and technical protocols from CMOs, ensuring compliance with regulatory standards and achieving 100% on-time documentation review
- Collaborate closely with CMOs to resolve quality issues efficiently, addressing 100% of identified gaps within set timelines and enhancing process improvements to meet BMS's quality standards
- Approve more than 100 GMP documents each year, including deviations, CAPAs, change controls, CPV reports, APQR and validation protocols, which has resulted in 10% reduction in review times
- Execute the vector disposition process, verifying and approving documentation for over 100 batches annually, ensuring production schedules are met
- Facilitate effective communication between external manufacturing teams and internal stakeholders, leading to a boost in operational efficiency for QA activities
- Contribute in the audit readiness activities, supporting 3 different audits and regulatory inspections, contributing to successful outcomes
Quality Assurance Manager
06.2020 - 06.2022
- Recruited, trained, and mentored a team of five investigation approvers, increasing team capacity by 50% to meet growing quality requirements and organization
- Led the review and approval of critical investigations, ensuring compliance with regulatory standards, and maintaining a 100% adherence rate to department and corporate guidance
- Implemented a training qualification program in collaboration with the training team reducing unnecessary training requirement by 20%
- Collaborated with site leaders to gain alignment on Corrective and Preventative Actions, achieving a reduction in deviations and compliance-related events
- Defined team goals ensuring its alignment with corporate objectives and achieving performance improvement over key reporting periods by focusing on opportunity areas
- Partnered with the Global Cell Therapy Team to execute more than 5 continuous improvement projects, enhancing the deviation and CAPA processes
- Executed risk assessments and approvals, reducing process risks by 20% and ensuring patient safety during manufacturing
- Supported GMP FDA and EU audits by finalizing response actions and preparing for deviation investigation presentations, contributing to successful inspection outcomes
Senior Quality Assurance Supervisor/Quality Assurance Specialist
10.2018 - 05.2020
- Led GMP deviation investigations approvals, maintaining a 100% compliance rate with GMP regulations and improving the investigation completion rate by 20%
- Expedited and finalized investigations, consistently meeting the site goal of closing cases within 30 days from the compliance due date, achieving a closure rate of 95%
- Executed and closed corrective and preventative actions across the site, reducing repeat incidents by 25%
- Trained and coached over 50 employees across multiple departments on quality procedures, improving process compliance by 30%
- Evaluated and sanctioned more than 10 risk assessments, including end-to-end cell processes and cross-contamination, enhancing processes
- Attained certification in the Kepner-Tregoe (KT) method of Root Cause Analysis, enhancing investigation accuracy and root cause analysis of OOS deviation by 100%
Summary of Manufacturing and Quality experience
Genentech
05.2000 - 10.2018
- Led and streamlined quality processes across Quality Assurance, Manufacturing, and Purification teams using LEAN methodologies, enhancing discrepancy closure rates, and reducing compliance issues by significant margins
- Managed corrective and preventative actions (CAPAs), successfully reducing site-wide discrepancies while developing onboarding training programs that improved time-to-competency for new employees
- Designed and implemented training programs for over 90 employees across multiple departments, facilitating skill development, increasing operational efficiency, and improving compliance with quality procedures
- Supported regulatory success during GMP health inspections (e.g., FDA and international agencies), contributing to the licensing of new facilities and successful product launches
- Directed cross-functional collaboration between departments by serving as a subject matter expert (SME), ensuring reliable execution of operations, maintenance compliance, and seamless communication across shifts
- Led continuous improvement initiatives, coordinating more than 30 change records in purification to ensure right-first-time changes, achieving 100% reliability for key processes
- Analyzed complex risks and discrepancies via Kepner-Tregoe analyses and advanced risk assessment processes, driving operational improvements that eliminated floor bioburden excursions and improved equipment reliability
- Developed user specifications and validated new drug product campaigns, including international technology transfers and troubleshooting efforts in manufacturing facility
- Led ergonomics and safety initiatives, implementing tools to reduce injury rates while enhancing operational safety, particularly in manufacturing
- Played pivotal roles in production expansions, including debugging, troubleshooting, and validation for new manufacturing facilities and Distributed Control System upgrades
Education
Bachelor of Science - Microbioloy and Fermentation
University of California at Davis
Skills
- Root cause analysis
- Problem-solving methodologies
- 5 Whys technique
- Fishbone diagram analysis
- Fault tree analysis
- Kepner-Tregoe methodology
- Validation processes
- Verification techniques
- IQ, OQ, and PQ validation
- Supplier quality management
- Supplier re-qualification processes
- Performance monitoring strategies
- Risk assessment methodologies
- Current Good Manufacturing Practices (CGMP)
- Regulatory compliance standards
- FDA and EMA compliance
- Global regulatory frameworks
- Quality management systems (QMS)
- Veeva and TrackWise expertise
- document control practices
- deviation management
- Corrective and preventive actions (CAPA)
- audit management and inspections
- Change management strategies
- Change control systems
- document tracking and management
Timeline
Quality Assurance Manager
External Quality Vector CMO
06.2022 - Current
Quality Assurance Manager
06.2020 - 06.2022
Senior Quality Assurance Supervisor/Quality Assurance Specialist
10.2018 - 05.2020
Summary of Manufacturing and Quality experience
Genentech
05.2000 - 10.2018
Bachelor of Science - Microbioloy and Fermentation
University of California at Davis
Similar Profiles
JOHN O'HAVERJOHN O'HAVER
Fractional CMO at Fractional SMB CMOFractional CMO at Fractional SMB CMO
PADMINI MURTHYPADMINI MURTHY
Fractional CMO at PM CMO ConsultingFractional CMO at PM CMO Consulting
Rebeca ChiesaRebeca Chiesa
Care Manager at Tri County CMOCare Manager at Tri County CMO