Sam Ross

Sam Ross Email and Phone Number

Director Of Quality Project Management at ImmunityBio @ ImmunityBio, Inc.
Sam Ross's Location
United States, United States
Sam Ross's Contact Details

Sam Ross personal email

n/a
About Sam Ross

Sam Ross is a Director Of Quality Project Management at ImmunityBio at ImmunityBio, Inc.. He possess expertise in gmp, u.s. food and drug administration, quality system, corrective and preventive action, pharmaceutical industry.

Sam Ross's Current Company Details
ImmunityBio, Inc.

Immunitybio, Inc.

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Director Of Quality Project Management at ImmunityBio
Sam Ross Work Experience Details
  • Immunitybio, Inc.
    Director Of Quality Project Management
    Immunitybio, Inc. Dec 2021 - Present
    San Diego, Ca, Us
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  • Immunitybio, Inc.
    Associate Director Of Quality Project Management
    Immunitybio, Inc. Sep 2019 - Jan 2022
    San Diego, Ca, Us
    Responsible for leading cross-functional global projects across the Quality business units. These includes project management of Quality responsibilities supporting N-803: packaging and labeling, shipping validation, 3PL and distribution. In addition, support project management of QC sampling and specification of Adeno COVID, VSS, DS/DP. Support development of Quality Management Systems. Responsible for the following Standards: Data Integrity, Phase Appropriate GxP, and Inspection Management. Assist in development and execution of training program. Support CMO and supplier audits. Organize and facilitate Quality Leadership meetings and all quality quarterly meetings. Maintain Quality’s organizational and functional chart. Plan and coordinate all financial, strategic, and operational activities for the Quality department. This includes working with Finance on fiscal year budget and tracking monthly spend. Lean certified; facilitate continues improvement initiatives.
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  • Takeda
    Manager Of Quality Systems
    Takeda Jan 2019 - Sep 2019
    Tokyo, Jp
    Responsible for managing the site’s Quality Management System including leading improvement projects on quality metrics.• Managed a team responsible for annual product quality review, deviations, change control, management review, quality agreements, and documentation management.• Supported Pre-Approval Inspection (PAI) and licensure, this included PAI of Fractionation and Purification facility in Covington, Georgia.• Led Data Integrity initiatives to align compliance to new regulations and expectations in QC and Manufacturing.• Managed projects to reduce significant deviation cycle time and use of statistical analysis tool for setting appropriate effectiveness check criteria.• Conducted assessment of internal quality systems using applicable quality standards, global and/or local procedures, and applicable country regulations to ensure compliance.• Led improvements to key quality indicators and metrics and presented to Senior Leadership Team.• Led assessment of Quality Management System integration and communicate changes and impact to the site user community and management.• Facilitated new employee orientation on GMP regulations and compliance.
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  • Shire
    Manager Of Quality Regulatory Compliance
    Shire Jun 2016 - Jan 2019
    Tokyo, Jp, Jp
    Responsible for managing internal and external inspection program including zero critical finding initiatives and audit readiness state at all times.• Developed program to manage site’s top compliance risk and gaps, and supported team to mitigate risk.• Led quality and compliance improvement efforts to improve facility compliance in GxP and international regulatory requirements.• Conducted regulatory observation assessment to determine site’s risk of receiving the similar regulatory observations.• Led development of customer (internal) awareness and understanding of GMP program and regulations.
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  • Baxalta
    Quality Manager
    Baxalta Jul 2015 - Jun 2016
    Illinois, Us
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Sam Ross Skills

Gmp U.s. Food And Drug Administration Quality System Corrective And Preventive Action Pharmaceutical Industry

Frequently Asked Questions about Sam Ross

What company does Sam Ross work for?

Sam Ross works for Immunitybio, Inc.

What is Sam Ross's role at the current company?

Sam Ross's current role is Director Of Quality Project Management at ImmunityBio.

What is Sam Ross's email address?

Sam Ross's email address is sa****@****eda.com

What skills is Sam Ross known for?

Sam Ross has skills like Gmp, U.s. Food And Drug Administration, Quality System, Corrective And Preventive Action, Pharmaceutical Industry.

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