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QA Validation Manager

Job ID: req1708
Employee Type: exempt full-time
Facility: Frederick: G-WAY
Location: 7116 Geoffrey Way, Frederick, MD 21704 USA

The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc.  The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

Our core values of accountability, compassion, collaboration, dedication, integrity, and versatility serve as a guidepost for how we do our work every day in serving the public’s interest.  

 Position Overview:

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 other bio-therapeutics to address infectious diseases of global significance (HIV-AIDS, Influenza, Ebola, Zika, Malaria and Tuberculosis). The VCMP is responsible for the operation of a Frederick MD -based pilot plant facility engaged in GMP manufacture, testing, release and supply of Phase I /II clinical products for investigational use in the US and worldwide.

KEY ROLES/RESPONSIBILITIES

The QA Validation Manager will be responsible for:

  • Managing the Equipment Validation department consisting of a minimum of 2 Leidos staff and oversight of equipment validation contractors
  • Project management of equipment validation and requalification in accordance with SOPs, master plans, regulatory expectations and industry standards
  • Scheduling, planning, managing and following up on:  
    • validation activities
    • projects and deliverables
    • timelines
    • new equipment specifications
    • installation and use
    • facility/system/process improvement
    • equipment and system modifications and additions
    • requalification program
  • Timely development and completion of validation protocols and validation summary packages
  • Review and approval of validation work requests in the equipment management database, change control, and deviation system
  • Providing project status reports to QA and VCMP management
  • Participation in meetings with the client
  • Providing relevant reports and metrics both internally and to the client

BASIC QUALIFICATIONS

  • Possession of Bachelor’s degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a science or engineering field 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 six (6) years of experience in progressively responsible job-related experience
  • Minimum of four (4) years in a supervisory/manager role
  • Must have experience in a cGMP environment (biologics preferred)
  • Experience managing equipment validation projects
  • Knowledge of development of industry regulations and best practices
  • Expert knowledge in equipment validation and broad knowledge related to quality assurance
  • Ability to establish a validation strategy to manage multiple projects effectively and efficiently
  • Knowledge of current regulatory expectations and industry standards relating to compliance
  • Working knowledge of quality systems
  • Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

  • Project Management Professional (PMP) Certification
  • Experience supervising contractors

Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)

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