Mujtaba Ali Email & Phone Number

Accomplished Quality and Operational Consulting Executive focused on deploying compliant solutions. Strong Project Management skills with a track record for deploying successful Compliance, FDA remediation, Quality Systems, Validation, Supplier Quality and Technical Operations project. Track record of results in FDA regulated industries. Well-rounded entrepreneurial management style that cultivates excellence, promotes team development, and builds dynamic relationships at all levels.* Identified gaps with BLA, Process Val., SOP and Mfg. records for a site with Warning Letter. * Led a project implementing upgraded aseptic processes for a site with warning letter * Performed site audit(s) to assess GMP readiness for Gene Therapy Facility; Aseptic Facilities; and Other.* Developed Phase appropriate Quality systems for clients. * Supporting design of Gene Therapy Facility and Process* Acting Site Quality Head and Led a PAI Readiness Project for Antibody Drug Conjugate product: Activities included updating Quality System; built Quality Assurance Organization (hired over 30 staff members); oversaw release of product manufactured at CMO and local site; provided integral support for Data Integrity / Governance process; and hosted the FDA for the PAI inspection.

Consulting Quality Head for 1200 Pharma a clinical start-up company.

San Diego, California, Us

Overseeing Quality efforts for the Organization and supporting Cell Therapy and mAB manufacturing. As part of the role, providing Quality direction for the development of a mAB and Cell therapy Manufacturing facility and support processes; Supporting manufacturing of mAB and CAR-T products for Phase 1 trials through Supplier Quality oversight; QA processes oversight including plant QA operations, Quality Systems, Batch release, Audits, Release and Shipment of materials.

Irvine, Ca, Us

Led the Quality Function. During 2015 & 2016, Avrio Biopharma made substantial improvement in resolving 2015 FDA inspection issues. As part of these upgrades, Avrio implemented: a) full upgrade to the ISO 5 and ISO 7 areas; b) All open product contact areas are ISO 5 areas; c) Fully revalidated all utility, systems and equipments including WFI, Pure steam, Sterilization, Depyrogenation, Lyophilization, HVAC, Continuous monitoring alarm and others; d) Revamped its Quality system to be more risk based focus; e) Implemented Automated systems such as Master Control for document processing, ProCal for calibration / PM tracking, Lighthouse for Continuous Facility Monitoring and others.

South San Francisco, California, Us

Head of QA for Oceanside responsible for Quality Engineering & Validation, Change Control, Document Control and Risk Management. As a Leader, focus on Strategy, Accountability, Customer Service, Staff Development, Continuous Improvement, Team Collaboration and Financial Accountability.

San Diego, Ca, Us

Implemented the Amylin OH LLC project. Developed over 500K sq ft of pharmaceutical plant space. Scope included bulk manufacturing, filling and packaging area. Project was executed in less than 36 months.

Oversaw site operations for a biotech facility manufaturing a Allogeneic Immunotherapy Cell Therapy cancer vaccine. Support development of product in phase III clinical trials. Oversaw Operations functions.

Gaithersburg, Maryland, Us

Oversaw the validation effort for the Pre approval inspection of Medimmune's Frederick site.

Emeryville, California, Us

Directed the site operations and validation effort of this clinical phase III site.

Dublin, Ireland, Ie

Supported the aseptic filling expansion project in Raleigh site.

Master'S Degree, Manufacturing

Bs, Industrial Engineering