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Quality Assurance Director (Biologicals)

Job ID: req1821
Employee Type: exempt full-time
Facility: Frederick: ATRF
Location: 8560 Progress Dr, Frederick, MD 21701 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

Within Leidos Biomedical Research Inc. (operator of the Frederick National Laboratory for Cancer Research), the Clinical Research Directorate (CRD) provides clinical supervision of programs at the clinical end of the research spectrum. The quality assurance programs for the Vaccine Clinical Materials Directorate (VCMPD) and the Biopharmaceutical Development Program Directorate report through the CRD Directorate.  This reporting structure provides the required autonomy and transparency of Good Manufacturing Practice quality assurance operations. CRD also provides operational support for clinical research and supports clinical trials management, regulation, pharmacovigilance, and protocol development/protocol navigations. These support services include dedicated clinical research professionals who provide patient care to clinical trial participants at the National Institutes of Health (NIH) Clinical Center, and other research services that support the domestic and international clinical research initiatives of the National Cancer Institute (NCI), the National Institute of Allergy and Infectious Diseases (NIAID),  and several other institutes within NIH. . CRD’s support services are strategically aligned with its mission to provide comprehensive, dedicated support to assist NIH researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, protecting human subjects, and helping to advance scientific clinical research. CRD facilitates the conduct of NIH-sponsored  clinical trials that investigate the prevention, diagnosis and treatment of cancer, influenza, HIV, infectious diseases and emerging health challenges like Ebola virus and COVID-19, parasitic infections, heart, lung and blood disorders, and rare and neglected diseases. CRD’s collaborative approach to clinical research support and the expertise and dedication of staff to the continuation and success of CRD’s mission has contributed to improving the overall standards of public health on a global scale.

The Clinical Research Directorate (CRD)/Biopharmaceutical Development Program (BDP) provides support to the National Cancer Institute (NCI) and other government agencies’ through the development of novel agents for first-in-man clinical studies.

KEY ROLES/RESPONSIBILITIES

  • Responsible for CGMP and GLP compliance; change control, nonconformance, internal and external auditing, CGMP training, batch record review and lot release, documentation and label control, validation, metrology, and oversight of specification development, product manufacturing, evaluation, and support activities
  • Responsible for Regulatory Affairs; including CMC Development
  • Manages departmental budgets and projects
  • Interfaces with the NCI
  • Assists with biologic IND submissions
  • Strategizes, implements, and leads QA and Regulatory functions
  • Executes and administers the GxP quality system pertaining to GMP and relevant ICH, US, and EU regulations
  • Ensures overall quality and compliance oversight for manufacturing, clinical and supply chain activities
  • Establishes and maintains a phase-appropriate quality management system
  • Ensures appropriate quality oversight of external vendors, e.g., contact manufacturing organization (CMO), contract testing labs (CTL)
  • Plans and oversees day-to-day activities of the quality function including management of consultants, external auditors, internal quality functions, e.g., continuous improvement, training, compliance, document control, lot release, regulatory affairs, validation/calibration, and computer systems validation
  • Leads preparations and management of regulatory inspections and client audits
  • Provides leadership and mentorship of the quality team
  • This position is located in Frederick, Maryland

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 a related 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 ten (10) years of prior relevant experience
  • Eight (8) years of experience in a manager/supervisory capacity
  • Extensive knowledge and experience in GxP and QA principles, practices, regulatory and industry standards
  • Experience with using risk-based principles and decision making to ensure compliance at all stages of development
  • Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

  • Masters degree or PhD
  • Experience working in a small biopharmaceutical company producing Phase I/II clinical materials, including vaccines and biotherapeutics
  • Experience with parenterals
  • Regulatory Affairs Certification (RAC)
  • A strong team player with the ability to effectively communicate sound quality advice cross-functionally based on experience, regulations, and business needs
  • Proven track record of leadership and building relationships with both internal and external customers
  • Strong negotiation skills, flexibility and ability to provide a solution-based approach to emerging challenges

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

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