QA Regulatory Affairs Manager

Location
Frederick, MD, USA
Posted
Nov 12, 2018
Ref
req166
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time
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

Reporting to the Associate Director, QA Regulatory Affairs, the QA Regulatory Supervisor will perform tasks within regulatory affairs consisting of, but are not limited to, the following:
  • Manages all regulatory activities for new and mature products to ensure alignment and compliance with FDA and company policies
  • Manages (1) QA Regulatory Specialist
  • Draft and compile 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
  • Prepares amendments to CMC sections
  • Interprets FDA guidelines and regulations with guidance from management
  • Interacts with regulatory agencies on defined matters and during inspections
  • Assists 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

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 educational requirements, a minimum of eight (8) years job related experience
  • 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
  • Background in a functional discipline related to vaccine and biologics CMC is a plus (cell banking, upstream or downstream operations, validation, analytical testing, etc.)
  • 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 is desired.
  • Working knowledge of Microsoft Office
  • Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS
  • Two (2) years as a supervisor
  • Combination of QA and QC or manufacturing experience
  • Working knowledge of quality systems Experience with the GMP manufacturing of Phase I/II clinical material

Expected Competencies:
  • First level of managerial roles responsible for leaving a team of professionals and supervises large, complete technical and business support
  • Accountable for the short- to medium-term performance and results of a team within own discipline or function
  • Takes action to monitor and manage costs related to own work and that of the team
  • Impact is generally limited to the achievement of short- to -medium term goals; may be required to develop and manage operational initiatives to realize operational and strategic plans
  • Adapts departmental plans and priorities to address resource and operational challenges
  • Decisions are guided by policies, procedures and business plans; receives guidance from directors
  • In-depth knowledge of principles and practices within a professional discipline or multiple technical areas
  • Resolve issues that are differing, but related, by use of evaluation, judgment, and interpretation to help others select the right course of action; which may impact the longer term
  • Interprets and explains information to audiences who are not familiar with the subject matter often requiring persuasion and adaptation of presentation
  • Requires objective review of difficult work problems, obtaining cooperation or approval

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