QA Compliance Manager

Location
Frederick, MD, USA
Posted
Oct 25, 2018
Ref
req126
Hotbed
BioCapital
Required Education
Associate Degree
Position Type
Full time
Cancer Imaging Program (CIP) support includes oversight of radiopharmaceutical chemistry operations, clinical trials quality assurance support, medical imaging agent availability, regulatory affairs, and imaging informatics. Chemistry operations includes operation of a fully functional Radiopharmaceutical Drug Production (RDP) laboratory. Regulatory support efforts are focused on managing the life cycle of the CIP INDs, assisting with the advanced development of the CIP- and non-CIP-sponsored investigational imaging agents, supporting clinical trials, and providing access to CIP imaging agents. Oversight of imaging informatics, including leadership in numerous informatics communities and imaging networking endeavors.

KEY ROLES/RESPONSIBILITIES
  • 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 RDP Production, Quality Control, and related areas
  • Manages and performs audits of contract manufacturers, contract testing companies, raw material vendors, and related entities. Prepares reports to document audit results
  • 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 RDP
  • Manages safety, environmental, and facility issues
  • Maintains Radiation Safety Program for production laboratory
  • Evaluates QC of prepared bulk drug product
  • Responsible for the compounding, adhering to quality assurance, dispensing, and distribution of USP grade radiopharmaceuticals for Phase 0 and Phase I clinical trials
  • Participates in radiosynthesis and quality control, as required
  • In a team with radiochemists, research associates, and technicians, the QA Manager II will be involved in radiopharmaceutical production, quality control, and adherence to cGMP, SOPs and USPs while maintaining a clean environment in the laboratory
  • May also be required to participate in research and development activities, like testing new radiopharmaceuticals and quality control aspects
  • Ensures compliance with all regulatory commitments and procedures and other applicable Federal, State and Local authorities
  • Other tasks as assigned by supervisor

BASIC QUALIFICATIONS
  • 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). Foreign degrees must be evaluated for U.S. equivalency.
  • 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 radiopharmaceutical industry, including two (2) years of experience in a leadership capacity
  • At least 3 years of experience in USP Radiopharmaceutical Drug Production
  • Communicates effectively with a proven ability to interpret information and provide and/or follow complex instructions
  • Ability to work independently and/or as part of a cross-functional team
  • Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS
  • GMP manufacturing, testing, documentation, and support experience
  • GMP compliance and training experience
  • Prior experience with USP Radiopharmaceutical Drug Production
  • Experience in nuclear pharmacy, PET manufacturing, staff training, and/or comparable laboratory operations
  • Quality Assurance compliance experience
  • Supervisory/management experience
  • Skilled at negotiation
  • Previous auditing and investigation experience

Expected Competencies:
  • Strong English language written and verbal communication skills
  • Team player with ability to work well with others
  • Experience in compounding of radiopharmaceuticals for clinical trials
  • Demonstrated experience implementing and ensuring compliance with company policies and procedures
  • Actively participate in and follow established radiation safety procedures including developing and executing an approved Radiation Program
  • Able to receive, compound, prepare, and fill written directives; ship bulk radiopharmaceutical drugs
  • Maintaining inventory according to established written procedures
  • Deliver and ensure performance of aseptic techniques, including sterility test and pyrogen testing per company standard operating procedures
  • Able to perform QC procedures using analytical equipment and chemical tests per company standard operating procedures
  • Maintains all applicable documents and records in a neat and organized fashion
  • Prepares shipment of radioactive materials according to procedure and licensing authorities requirements