Drug & Device CMC Consultant

Our client, a leading pharmaceutical company focused on discovering, developing, manufacturing, and commercializing therapeutic treatments is currently seeking a Drug/Device Combination CMC Consultant to join their Quality Assurance team for a 6-month contract with the potential to extend. This person will be responsible for assisting in CMC QA activities to support clinical development, submission, and approval of drug-device combination product.

Responsibilities:

  • Support device design control activities and documentation reviews
  • Preparation of Device History File
  • Preparation of Human Factor Risk Analysis
  • Performs Archival of QA Records in EDMS (e.g., CMO batch records, data packages)
  • Conduct follow up on Action Items for Quality Leadership Team (QLT) meetings
  • Assist with generation of Metrics and Metrics reports
  • Performs Data Entry into GxP Regulated Systems as required
  • Manages events/CAPAs in electronic quality management system (EQMS), including data entry, tracking, and follow-ups with Owners to drive completion
  • Coordinates document approval, as necessary
  • Schedules and coordinates meetings for CMC Quality Operational team (Leadership meetings, Extend group meetings)
  • Manages agenda and minutes and follows up on all action items

Salary: $90-100/hr

Qualifications:

  • Medical Device experience required
  • Strong understanding of regulations, guidelines, procedures, and policies relating to development, registration, and manufacturing of drug-device to expedite the submission, review and approval of global CMC applications
  • Bachelor’s degree and 0 – 3 years of relevant work experience in the Biotech or Pharmaceutical industry, or relevant comparable background

 

If you are interested in this position, please send your resume to msabia@daleyaa.com

#LI-MS1
IND123

 

Attach a resume file. Accepted file types are DOC, DOCX, PDF, HTML, and TXT.

We are uploading your application. It may take a few moments to read your resume. Please wait!