Ruel M. Garcia

Director, Quality Systems and Compliance at Keros Therapeutics

Ruel M. Garcia has a diverse work experience spanning several decades. Ruel M. has held various positions in different companies, demonstrating their expertise in quality systems and compliance.

In their most recent role at Keros Therapeutics, Ruel serves as the Director of Quality Systems and Compliance, starting in 2023. Prior to this, they worked at Spectrum Pharmaceuticals, Inc., where they held the positions of Associate Director of Quality Systems and Associate Director of Quality Operations from 2020 to 2022. In these roles, Ruel played a crucial role in the development and implementation of quality functions and management systems, ensuring compliance with GxP (Good Clinical Practice) standards.

Before joining Spectrum Pharmaceuticals, Ruel worked at Arbor Pharmaceuticals LLC as a Senior Manager of Supplier Quality. During their tenure, which lasted from 2014 to 2020, they established and managed the Supplier Quality Systems to ensure compliance with regulatory requirements. Ruel M. also oversaw the qualification of external suppliers and manufacturers, emphasizing continuous improvement and risk management.

Prior to their time at Arbor Pharmaceuticals, Ruel held several positions at Actavis (now Abbvie), Watson Pharmaceuticals Inc., and Watson Laboratories Inc. Ruel M.'sroles involved coordinating and tracking projects, managing quality operations, reviewing and approving documentation, and conducting audits to ensure compliance with quality standards and regulatory requirements.

Ruel's early career involved roles at Biovail Corporation, Masterwayprint Canada Inc., and Wyeth Philippines Inc. At Biovail Corporation, they served as a Quality Assurance Auditor and Technical Writer/Reviewer, contributing to the development of standard operating procedures and ensuring data accuracy in the quality control department. At Wyeth Philippines Inc., Ruel held positions as a Quality Assurance Supervisor, HPLC Analyst in Quality Control, Process Inspector in Quality Control, and Chemical Analyst in Quality Control, where they conducted various quality testing and inspections to uphold cGMP standards.

Overall, Ruel's work experience exhibits their extensive knowledge and expertise in quality systems, compliance, supplier management, and project coordination in the pharmaceutical industry.

Ruel M. Garcia holds a Bachelor's degree in Chemical Engineering from Universidad de Zamboanga. In addition to their degree, they have obtained several certifications throughout their career. These certifications include GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus) from CITI Program, Investigations and CAPA Instructor Led Training from PathWise, Data Integrity Level 1 to 3 from Green Mountain QA, Certified Manager of Quality/Organizational Excellence (CMQ/OE) from ASQ - World Headquarters, Certified Quality Auditor (CQA) from ASQ - World Headquarters, and Certified Quality Engineer (CQE) from ASQ - World Headquarters.

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Timeline

  • Director, Quality Systems and Compliance

    June, 2023 - present

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