Haitham Ali

Experience

• 

  Sidi Barrani military hospital

  Jan 2004 - Mar 2005

  Pharmacist

  Counter Pharmacist

• 

  Sanofi-aventis

  May 2005 - Apr 2006

  Medical representative
• 

  Roche Pharmaceuticals

  Apr 2006 - Mar 2007

  Oncology specialist
• 

  Novo Nordisk

  Mar 2007 - now

  My mission as head of quality function is to ensure product quality/safety and ensure protection of the license to operate through:• Strategic Planning: Develop & execute short and long-term quality strategy• Leadership: Coach, mentor, & develop Quality team• Collaboration & Partnership: Build strong relationships with internal operations teams & external partners• Establishment & maintenance of the Quality Management System: Ensure local procedures are created/maintained in accordance with internal global procedures & authority regulations• Managing audits/inspections:o Drive & coordinate yearly audit program based on risk assessmento Develop & train auditorso Peer-review audit reportso Ensure sufficiency of proposed audit finding corrective & preventive actionso Host/manage internal audits & inspections received by the unit• Authority & Internal Requirements Monitoring: Ensure GxP functions are up-to-date with internal global & authority requirements• Management Review, Risk assessment and Continual Improvement: Lead Management Review process, where potential risks & opportunities for improvement are identified/assessed & develop risk mitigation & improvement plan• Compliance Performance Monitoring: Monitor/manage compliance performance by analyzing internal data metrics & report KPIs• Non-conformance & Change Management: o Investigate root-cause of deviations & develop/implement CAPAso Ensure GxP changes executed/documented in compliance with relevant requirements• External Suppliers Oversight: o Oversee distribution of products to ensure product quality, safety & effectivenesso Ensure release of products in accordance with cGMP/cGDP requirementso Oversee repackaging activitieso Own creation & maintenance of quality agreements with third partieso Ensure third parties’ activities are supported & audited• Management of critical product related issues such as recalls• Establishment of quality mind-set, awareness & training Show less In this position I was leading both Quality Assurance and Drug Safety units in Gulf Region (a zone of 7 countries).In addition to the responsibilities of my current role in Australia, I held the below additional responsibilities:• Ensure compliance of post market activities with authority Good Vigilance Practices (GVP)• Ensure effective and timely handling of patient complaints and drug safety reports• Oversee timeliness of safety reporting across the zone• Ensure safety signals are reported timely to health authorities• Be the registered Qualified Drug Safety Responsible Person (QPPV)• Be the focal point of contact with health authorities• Own and drive product recall process Show less

  • Quality Assurance & Project Leader

    Sept 2019 - now

  • Head of Quality Assurance and Drug Safety - Gulf Region

    May 2009 - Sept 2019

  • Product Sales Specialist

    Mar 2007 - May 2009