Syed Ali
Senior Technical Manager, Global Supplier Quality @Roche
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WORK HISTORY
Senior Technical Manager, Global Supplier Quality @Roche
Mississauga, ON, CA
Lead complex cross-functional (internal and external) projects related to GxP Supplier and materials management in alignment with Roche and Genentech\'s cell and gene therapy/new modalities master plan and within expected timelines (100%)-Support strategy deployment for Supplier Quality Management driven projects-Responsible for the full lifecycle E2E management and oversight of GxP Suppliers for Roche/Genentech\'s CGT/ATMP clinical programs-Responsible for leading GxP Supplier Qualifications utilizing a risk based approach -Overseeing supplier audits and negotiating quality agreements for new and existing suppliers-Support deployment of Policy, Quality Requirements/standards/directives and procedures-Support the implementation of consistent processes and systems across global regions and the platforms-Report metrics and Key Process Indicators (KPIs) for pertinent projects-Oversee required quality activities related to technical transfers of Direct Materials-Drive Continuous Improvement objectives through E2E process and metrics review-Support Health Authority inspections at Roche/Genentech sites and share Lessons Learned with stakeholders and Roche internal sites as required-Take an active role to improve regulatory compliance by keeping up to date with relevant requirements-Monitor supplier performance; Develop metrics and issue monthly metric reports for assigned projects-Processing supplier related changes that impact regulatory / GMP process-Leading supplier related deviations investigations and driving effective supplier CAPAs to completion
EDUCATION
Seneca Polytechnic
Graduate Certificate, Pharmaceutical Regulatory Affairs and Quality Operations
University of Toronto Mississauga
H.BSc., Molecular Biology
SKILLS
ABOUT SYED ALI
Results-driven, high-energy, self-motivated industry leader, turning dreams into reality and pushing the needle towards successStrategic Quality Leader with over 10 year of experience leading and delivery quality and compliance initiatives and projects that meet both regulatory/health authority expectations and internal budgets and project timelines.I am a detail oriented, hands on manager with a strong background in cGMP pharmaceutical and biotechnology industries. I have several years of experience managing people and projects to deliver excellent results and provide value to customers and stakeholders by effectively leveraging team, supplier and customer relationship skills. My expertise encompasses both regulatory and quality systems and compliance management in small and large molecules/biologics, innovators, generics, Cell & Gene Therapies/Advanced Therapy Medicinal Products (ATMPs) and medical device organizations.
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