QA Compliance Manager

Location
Frederick, MD, USA
Posted
Oct 24, 2018
Ref
JR81-70094
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time
The Biopharmaceutical Development Program (BDP) of Leidos Biomedical Research, Inc. supports the National Cancer Institute (NCI) and other government agencies through the development of novel agents for first-in-man clinical studies.

KEY ROLES/RESPONSIBILITIES

THIS POSITION IS CONTINGENT ON FUNDING APPROVAL
  • Oversees the development, implementation and maintenance of quality assurance systems and activities in conformance with Good Manufacturing Practices (GMP)
  • Oversees generation and review of documents used in GMP
  • Manages and performs audits of BDP Production, Quality Control, and related areas
  • Manages and performs audits of contract manufacturers, contract testing companies, raw material vendors, and related entities. Prepares reports and documentation
  • Manages and performs GMP and related training
  • Manages and leads non-conformance related investigations, manages corrective and preventative actions (CAPA), and manages potential quality issues
  • Evaluates, selects, and develops personnel to ensure GMP compliant and efficient operation of the BDP

BASIC QUALIFICATIONS

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:
  • Possession of a Bachelor's degree from an accredited college or university, according to the Council for Higher Education Accreditation, in the life sciences or related discipline, e.g. microbiology, biology, biochemistry, medical technology, etc. (Additional qualifying experience may be substituted for the required education)
  • In addition to educational requirements, a minimum of six (6) years of progressively responsible job-related experience in a GMP or related compliance position in the pharmaceutical, biopharmaceutical, &/or biologic industries including two (2) years of experience in a leadership capacity
  • Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS:

Candidates with these desired skills will be given preferential consideration:
  • GMP manufacturing, testing, documentation, and support experience
  • Knowledge or prior experience with Cell Therapy and or Blood Products
  • GMP compliance and training experience
  • Quality Assurance compliance experience
  • Supervisory/management experience
  • Skilled at negotiation
  • Previous auditing and investigation experience

Expected Competencies:
  • Strong written and verbal communication skills
  • Team player ability to work well with others


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