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Quality Systems, Manager

Company: Theragent Inc
Location: Arcadia
Posted on: January 10, 2022

Job Description:

What We Do
Theragent is a privately-owned Contract Development and Manufacturing Organization (CDMO) focused on novel Cell and Gene Therapy medicines to meet unmet patient needs. We are a small, biotech startup headquartered in Arcadia, CA. Our state of the art facility provide high-quality, reliable, and value-added solutions to our clientele for challenging pre-clinical and clinical trial projects. Our innovative cGMP facility offers comprehensive end-to-end manufacturing and testing capabilities for clinical and commercial purposes.
Why Theragent?
Take the next step in your career and join Theragent today to change patient lives through the products we help develop and manufacture. Here, you will contribute your talents in a purposeful way that impact the lives of patients around the world. You will develop as an individual by working directly with a team of seasoned experts and rising stars. Our values of Innovation, Transparency, Accountability, Integrity, Diversity, Humility to name a few are embedded in everything we do. No matter your role may be, Theragent strives to ensure all our teammates are empowered and given the necessary tools to lead us in our relentless pursuit to extending patient lives.
Our Mission:
To Manufacture and Deliver high-quality, reliable, and value-added Therapeutic Solutions for Biopharma clients and patients.
Position Summary:
The Quality Systems Manager will have a unique opportunity to build the Quality Systems from the ground up for a Cell and Gene therapy biotech startup. The Quality Systems Lead/Manager will partner and collaborate with Quality and Operations Leadership to develop systems/processes that support efficient and effective operations.
The role is responsible for assuring quality standards and regulatory compliance are consistent with Government regulations, International standards, and lead the continuous improvement of the Quality Systems in Theragent.
This role has direct responsibility in building Quality Management System across Theragent organization. In addition, he/she will manage and direct a group of quality professionals dedicated to the implementation and support of the quality processes.
Primary Responsibilities:

  • Build, Maintain and Improve the Theragent Quality System.
  • Supervises and mentors Quality Systems staff.
  • Collaborates with Functional Area leaders for continuous feedback on the Quality System.
  • Participates and supports internal and external regulatory site visits, inspections, and audits. This includes pre/post inspection activities are completed.
  • Act as technical expert for regulations and standards including 21CFR820 requirements, ICH guidelines.
  • Assists with establishing quality standards and conducts training on the standards
  • Manages and strengthens key Quality Systems processes.
  • Trains, develops, and provides technical guidance to other staff.
  • Actively participates in quality guidance and helps project and quality teams for process improvement, standardization initiatives, and continuous improvement activities.
  • Completes projects/program activities and other duties as assigned.
    Reports to: Site Director of Quality
    Knowledge, Skills & Abilities:
    • Knowledge of ICH, cGMP, GLP, GAMP, 21 CFR 211, 21 CFR part 11.
    • Experience in the qualification of cell therapy equipment a plus.
    • Ability to develop, delegate and motivate others including direct and indirect reports.
    • Strong written and verbal communication skills.
    • Experience with investigations, change controls, CAPAs, and Audits..
    • Excellent interpersonal skills with experience dealing with a diverse workforce.
    • Strong multi-tasking ability in conjunction with proven organizational skills.
    • Ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion.
    • Ability to effectively manage multiple tasks and activities simultaneously.
    • Highly proficient computer skills in Microsoft Office Suite - Word, Excel, PowerPoint and Outlook.
    • Innate ability to learn new software, such as corporate intranet and enterprise business.
      Competencies:
      • Self-driven, Resourceful and current with FDA regulations
      • Strong communication skills in small and large group settings
      • Strong team player
      • Experience with Quality Management IT systems
      • Trainer in a GMP Manufacturing environment is a plus
      • Strong Organizational and Time Management Skills
      • Understanding of cGMP regulations and aseptic practices, preferably with Cell Therapy
        Education & Professional Experience:
        • BS/BA in engineering/biology/scientific field..
        • Minimum of 5 years experience in FDA-regulated industry.
        • Knowledge of cGMP in the pharmaceutical industry. Application to cell/gene therapy a plus.
        • Experience with electronic Quality Systems.
        • 5+ years of supervisory experience with direct reports.
          Working Conditions:
          Travel: Occasional, less than 10%
          Physical / Mental Demands:
          • Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting up to 25lbs.
          • Ability to sit, stand, walk and move within workspace for extended periods.
          • Ability to perform repetitive tasks including hand to finger manipulations, grasping, pushing and pulling.
            Environmental Conditions:
            • Primarily office environment but will be required to enter laboratory or GMP process areas donning proper gowning / lab coats or PPE such as safety glasses and shoes.
            • Ability to work safely and effectively when working alone or working with others.
              * This description outlines the basic responsibilities and requirements for the position noted. This is not a comprehensive listing of all job duties of position. Duties, responsibilities and activities may change at any time with or without notice. *Theragent Inc is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status, and veteran status. All qualified applicants will receive consideration for employment.

Keywords: Theragent Inc, Arcadia , Quality Systems, Manager, Executive , Arcadia, California

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