Leidos QA Regulatory Affairs Specialist (NCI) in FREDERICK, Maryland

Description

PROGRAM DESCRIPTION

The Vaccine Clinical Materials Program (VCMP) is responsible for the overall direction of the operations/manufacturing of the vaccine and biotherapeutic development facility for the development of experimental therapeutics for pre-clinical and Phase I and II clinical trials targeting a range of infectious diseases.

KEY ROLES/RESPONSIBILITIES-THIS POSITION IS CONTINGENT UPON FUNDING APPROVAL

Reporting to the QA Regulatory Affairs Supervisor the QA Regulatory Specialist will perform tasks within regulatory affairs consisting of, but not limited to, the following:

  • Draft in eCTD format Chemistry, Manufacturing and control (CMC) documentation required for Investigational New Drug (IND), and Drug Master Files filed with the FDA or other regulatory agencies, using batch records, quality control test reports and SOPs

  • Prepare amendments to CMC sections

  • Interpret FDA guidelines and regulations with guidance from management

  • Participate in interactions with regulatory agencies on defined matters and during inspections

  • Assist team by providing regulatory guidance to investigators, contractors and staff

  • Prepare responses to CMC comments from regulatory authorities

  • Prepare and submit to the client for approval regulatory documents supporting clinical trials

  • Coordinate the shipment of release drug product to clinical sites

  • Process import permits to support shipments of clinical trial material

  • Track the life-cycle of clinical trial material and CFR reserves

  • Process investigations of product complaints

  • Review and approve change controls for regulatory impact

  • Revise SOPs for process improvements

  • Draft and provide regulatory reports to QA management

Qualifications

BASIC QUALIFICATIONS

  • Possession of a Bachelor’s degree from an accredited college/university in a scientific discipline according to the Council for Higher Education Accreditation (CHEA). (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency.

  • In addition to education requirement, a minimum of five (5) years job related experience, or a minimum of three (3) years of experience in a cGMP environment

  • Experience in regulatory submission preparation in accordance with eCTD format, ICH, and US requirements

  • Experience with technical writing or compiling of the CMC section of INDs for vaccines and biologics

  • Working knowledge of FDA and international biologics/drug regulations

  • Working knowledge of regulatory initiatives including ICH, USP and other regulatory intelligence sources

  • Previous experience in GCP, GLP, or GMP regulated environment

  • Working knowledge of Microsoft Office

  • Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

  • Combination of QA and QC or manufacturing experience

  • Working knowledge of quality systems

  • Experience with the GMP manufacturing of Phase I/II clinical material

  • Background in a functional discipline related to vaccine and biologics CMC (cell banking, upstream or downstream operations, validation, analytical testing, etc.)

Expected Competencies:

  • Career-level (fully competent) experienced professional able to carry out a full range of professional duties, by working independently and receiving minimal guidance

  • Provides professional know-how to enhance the knowledge and skill base of the organization

  • Accountable for meeting own target which will impact the discipline

  • Impact is limited to the achievement of short- to medium-term goals

  • Contributes to delivery of discipline / department goals through personal effort or through influence over team members

  • In-depth knowledge of principles and practices within a professional discipline

  • Uses best practices and knowledge of internal or external business issues to improve products or services and suggests variations in approach

  • Devises solutions based on limited information and uses past experience, evaluation, and interpretation to identify solutions or to adapt existing approaches to resolve issues; which may impact the longer term

  • Solves complex problems; takes a new perspective using existing solutions

  • Requires strong multicultural awareness to appropriately deliver messages and adapts style to differing audiences

  • Acts as a resource for colleagues with less experience; may direct the work of other staff members

REQNUMBER: 663054

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status. Leidos will consider qualified applicants with criminal histories for employment in accordance with relevant Laws. Leidos is an equal opportunity employer/disability/vet.