QA Manager (cGMP)


Elkridge, MD
USD 130,000.00 per year
Full Time


DocumentationBiologyGood manufacturing practiceManagementTestingSupervisionManufacturingSpecificationManufacturing operationsQuality assuranceFDABiotechnologyChemistryLife sciencesInternal auditingAuditingPharmaceutics

Job Details

Piper Companies is actively seeking a Quality Assurance (QA) Manager (cGMP) for a biotechnology organization in the Greater-Baltimore, MD. The QA Manager will m anaging the established CEL-SCI's internal and external audit program by performing internal audits of current Good Manufacturing Practices (cGMP) processes and documentation supporting the manufacture and testing of a biopharmaceutical drug as well as perform external audits of suppliers and vendors of materials and services. The Manager of Quality Assurance reports directly to the Vice President of Quality Assurance.

Responsibilities of the QA Manager:
  • Review, approval and release of raw materials for use in cGMP manufacturing and testing
  • Participate as QA floor representative during manufacturing operations
  • Managing the internal audits on suppliers/vendors
  • Managing the established internal audit program
  • Initiation, tracking and closure of Deviations, Change Controls, CAPAs and Out of Specification events
  • When appropriate, assist in FDA inspections regarding regulated activities
  • Responsible for managing the external audits on suppliers/vendors
  • Responsible for managing the established external audit program
  • Review and approve executed cGMP documentation and other documents relating to cGMP activities
  • Initiate new SOPs and/or revise existing SOPs as needed
  • Review and approve timesheets and leave requests
  • Organize and chair departmental staff meetings
  • Perform annual reviews of Quality Assurance staff

Requirements of the QA Manager:
  • Bachelor's degree in life sciences, preferably biology or chemistry, or equivalent work experience
  • 5+ years' experience in a cGMP Quality Assurance role in the pharmaceutical, biotechnology or biopharmaceutical industry
  • 3+ years supervising a Quality Assurance department
  • Must be eligible to work in the US

Benefits of the QA Manager:
  • Full Medical, Dental, Vision, 401k, PTO, etc.
  • Salary up to $130,000 commensurate with experience