Manager, QA Computer System Validation (req2004)

Posted: 7/29/2021
Location: Frederick, MD
Employee Type: exempt full-time
Job ID: req2004

PROGRAM DESCRIPTION

The Vaccine Clinical Materials Program (VCMP), part of Leidos Biomedical Research at the Frederick National Lab, supports the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC). Its' mission is to advance preclinical and clinical research, product development, and manufacture of novel clinical-stage vaccines and biologics to address current and/or emerging infectious diseases of global significance (e.g. HIV-AIDS, Influenza, Ebola, Malaria, Novel Coronavirus, Tuberculosis). The VCMP is responsible for the operation of a Frederick MD -based pilot plant facility and is actively engaged in cGMP manufacture, testing, release, and supply of Phase I /II clinical products for investigational use in the US and globally.

KEY ROLES/RESPONSIBILITIES

Reporting to the QA Associate Director of Compliance / Continual Improvement / Training / CSV, the Computer System Validation (CSV) Manager will:

  • Define the CSV approach for the validation of new implementations and revalidation after modifications to existing software to ensure that application remains in a validated state
  • Ensure compliance with VCMP Pilot Plants Standard Operational Procedures (SOPs), System Level Procedures (SLPs), Code of Federal Regulation (CFR) and cGMPs
  • Collaborate with QA, IT, business stakeholders and vendors to ensure successful planning, execution, and delivery of validation projects
  • Gather and analyze requirements from business stakeholders
  • Author validation and testing documentation such as risk assessments, GMP assessments, 21 CFR Part 11 assessments, validation plans, user requirement specifications, functional requirements specifications, system design specifications, test plans, test cases/test scripts, traceability matrix, test summary reports, and validation summary reports
  • Coordinate system testing effort and identify/investigate deviations to determine the impact on the product quality, root cause and corrective actions required
  • Develop application workarounds, as necessary
  • Facilitate the development of SOPs to reflect the operation of specific systems
  • Facilitate the development of system training materials

BASIC QUALIFICATIONS

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

  • Possession of Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in science, computer science or a technical discipline or four (4) years relevant experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency
  • In addition to the education requirement, a minimum of four (4) years of progressively responsible experience to include computer software and/or system validation, including two (2) years of experience in a leadership capacity
  • Must have knowledge of current regulatory expectations and industry standards relating to computer system validation
  • Experience with validation and/or configuration of commercial-off-the-shelf (COTS) systems (e.g. TrackWise, EDMS, LIMS), analytical instruments and spreadsheets in a GXP environment
  • Understanding of GAMP5 and risk-based approach to validation
  • Thorough understanding of regulatory-compliance issues (21 CFR Part 11) and the system development lifecycle process (SDLC)
  • Experience in writing and executing validation documentation
  • Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

  • Experience with Oracle, SQL, Crystal Report, Visual Basic
  • Experience troubleshooting computerized systems/equipment
  • Experience with non-conformance documentation including deviations, investigations, CAPAs, and change controls
  • Experience with the qualification of Information Technologies (IT) Infrastructure (i.e., servers, networks, and network components) following the GAMP IT Infrastructure Guide
  • Must be able to meet published timelines