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.

Qualifications

Basic Qualifications:

• BA or BS degree required

• 3 or more years of quality assurance experience required

• 3+ 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.

GAP Solutions provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job, email us at [email protected] . 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.