Computer Systems Validation Lead
Company: Quality Agents
Location: Rockville
Posted on: February 13, 2026
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Job Description:
Job Description Job Description Salary: TBD Quality Agents, LLC
offers validation and quality expertise to the pharmaceutical and
biotechnology industries. Our Computer Systems Validation Leads
work directly with our clients to support activities that include,
but are not limited to, documentation review and approval,
including change controls, assessment plans, risk assessment
reports, compliance plans, user requirements, system and user
acceptance testing protocols, traceability matrix, error
reports/defect report forms and summary reports. The individual
will contribute directly to the completion of projects through the
management of assigned contract personnel, development and
execution of validation change control documents, and development
and review of protocols, reports and data tables generated by peers
and contract personnel. Responsibilities include: Optimization of
CQV support process, including developing including developing
standards and KPI reports. Compile and analyze validation data and
make recommendations for changes and/or improvements Maintain all
documentation pertaining to computer systems validation Data
integrity qualification Participate in cross-functional project
teams including development & deployment teams as well as customer
Manufacturing, Engineering, Quality and other groups Some travel is
required Skill level & requirements: Experience with IQ, OQ, PQ
Final reports relating to Computer Systems Validation. Experience
writing validation master plans. Experience with Configuration,
design, data and traceability matrices. Validation experience with
automated systems is preferred Thorough knowledge of cGMP
regulations related to CSV including 21 CFR Part 11 Strong
knowledge of computerized system development life cycle approach is
required Strong leadership skills and the ability to work in
cross-functional team environments, as well as independently
Experience coordinating Quality documentation, specifically
qualification/Validation documentation Demonstrated excellent
leadership/Project Manager skills Strong technical writing skills
Excellent written and verbal communication skills The ability to
work and make decisions independently and have the flexibility to
adapt to changing priorities is required Minimum Requirements:
Bachelors degree in a technical discipline (i.e. Engineering,
Chemistry, Microbiology, Biology) 3 5 years Computer Systems
Validation background 3 5 years IT Quality Assurance / Validation
experience Current drivers license and auto insurance or other
means of independent transportation Quality Agents offers a full
suite of benefits for full-time employees including: Health, dental
and vision insurance Life, AD&D and Disability Insurance Health
savings account for participants in our health plan 401k retirement
plan Paid time off Paid holidays Quality Agents accepts
applications on an on-going basis in order to build a talent pool
of potential candidates. These applications remain open for
consideration, as positions become available, for one (1) year from
the date of application.After that time, or if your application
information changes, please submit your application again.
Keywords: Quality Agents, Washington DC , Computer Systems Validation Lead, Healthcare , Rockville, DC
