Quality Management Specialist

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 Assurance

Experience 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 Systems Experience supporting testing including test incident management

Experience 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 stakeholders

Preferred Qualifications:

Direct experience with electronic test execution software is preferred

Experience performing vendor assessments and internal audits is nice-to-have Experience performing GxP impact assessments, system risk assessments, validation assessments, and 21 CFR Part 11 assessments preferred

Experience with Computer Software Assurance preferred

Certified Quality Auditor, Quality Engineer, ISO Lead, or a related Quality Associated Certification preferred

Ability to obtain Public Trust clearance

Possession of excellent planning, organizational, and computer skills

Possession 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.

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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.