Quality Management Specialist

GAP SOLUTIONS INC; Bethesda (MD); On-site; USD 110,000 - 140,000; Full time

Job summary

GAP Solutions Inc is seeking a Quality Management Specialist to support NIH/NIAID quality systems. You will provide independent quality oversight for GxP computerized systems, ensuring CSA/CSV compliance and validated lifecycle activities.

The role requires 3+ years in a GxP IT QA environment, strong knowledge of 21 CFR Part 11 and ICH E6(R2), and experience writing SOPs, IQ/OQ/PQ, and training cross-functional teams.

Qualifications

• BA or BS degree required.
• 3+ years of quality assurance in a GxP IT environment.
• Experience with GAMP5, Computer Software Assurance, 21 CFR Part 11, and ICH E6 (R2).
• Experience writing SOPs and IQ/OQ/PQ documents.
• Ability to obtain Public Trust clearance.

Responsibilities

• Provide independent quality oversight for GxP regulated computerized systems.
• Guide teams in CSA/CSV compliance and validation activities.
• Develop and review SOPs, IQ/OQ/PQ, and validation plans.

Skills

GxP QA

GxP IT experience

Test incident management

SOP writing

Training others

Cross-functional collaboration

Quality oversight

Education

BA/BS degree

Tools

Electronic test execution software

Job description

Position Objective: Provide services as a Quality Management Specialist in support of the overall functions of the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID).Duties and Responsibilities:Serve as a Quality Management Specialist providing independent quality oversight for the implementation, validation, maintenance, and retirement of GxP regulated computerized systems.Apply thorough knowledge of GxP regulations, including Computer Software Assurance (CSA) and Computer System Validation (CSV), to guide teams in meeting compliance expectations.Recommend and collaborate on solution approaches, working both autonomously and with cross functional stakeholders to ensure systems meet regulatory and quality standards.Basic Qualifications:BA or BS degree required3 or more years of quality assurance experience required3+ years of experience working in a GxP IT environment or GxP Quality AssuranceExperience with quality standards and regulatory requirements including but not limited to GAMP5, Computer Software Assurance, 21 CFR Part 11, and ICH E6 (R2)Direct experience with supporting IT Projects such as GxP SystemsExperience supporting testing including test incident managementExperience with writing SOPs and/or reviewing validation plans, installation qualifications (IQ), operational qualifications (OQ), and performance qualifications (PQ)Experience providing training to cross-functional teams and key stakeholdersPreferred Qualifications:Direct experience with electronic test execution software is preferredExperience performing vendor assessments and internal audits is nice-to-haveExperience performing GxP impact assessments, system risk assessments, validation assessments, and 21 CFR Part 11 assessments preferredExperience with Computer Software Assurance preferredCertified Quality Auditor, Quality Engineer, ISO Lead, or a related Quality Associated Certification preferredAbility to obtain Public Trust clearancePossession of excellent planning, organizational, and computer skillsPossession of excellent oral and written communication skills*This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required by this position.To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.GAP Solutions provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job, email us at [e-mail]. You will need to reference the requisition number of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a requisition number will not be returned.Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other characteristics protected by law.