Quality Systems, Manager
Company: Theragent Inc
Posted on: January 10, 2022
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
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.
To Manufacture and Deliver high-quality, reliable, and value-added
Therapeutic Solutions for Biopharma clients and patients.
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
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.
- 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
- 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
Reports to: Site Director of Quality
Knowledge, Skills & Abilities:
- Knowledge of ICH, cGMP, GLP, GAMP, 21 CFR 211, 21 CFR part
- Experience in the qualification of cell therapy equipment a
- 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
- Excellent interpersonal skills with experience dealing with a
- Strong multi-tasking ability in conjunction with proven
- 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
- 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.
- Self-driven, Resourceful and current with FDA regulations
- Strong communication skills in small and large group
- 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.
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
- Ability to perform repetitive tasks including hand to finger
manipulations, grasping, pushing and pulling.
- 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
Keywords: Theragent Inc, Arcadia , Quality Systems, Manager, Executive , Arcadia, California
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