Principal Specialist, GMP-GDP Quality Assurance

Epizyme   •  

Virtual / Travel

Industry: Pharmaceuticals & Biotech

  •  

8 - 10 years

Posted 45 days ago

Key Responsibilities:


cGMP and GDP QA Function

  • Executed batch record review and batch disposition of Drug Substance, Drug Product and Finished Products (oral solid dosage forms, parenteral, and radio labeled materials)
  • QA representative on CMC project teams with Contract Manufacturing Organizations (CMOs) and Contract Labs
  • Contribute to vendor management program by evaluating questionnaires, audit reports and risk assessment documents for manufacturers, analytical laboratories, and other vendors
  • Review manufacturing, analytical and supply chain deviations and investigations
  • Review OOS/OOT investigations
  • Participate on CMC Change Control Board
  • Oversee generation and review of documents used in cGMP & GDP activities such as Quality Agreements, COAs, analytical validations/transfers, process validations, master & executed batch records, label proofs, specifications and change controls
  • Other Responsibilities
  • Contribute in a supporting role to cGMP (Current Good Manufacturing Practice) & GDP (Good Distribution Practice) PAI and associated commercial launch readiness initiatives
  • Contribute in a supporting role during partner due diligence activities and regulatory inspections
  • Track Key Process Indicators (KPIs) for reporting of Quality Metrics
  • Contribute to the development of SOPs, other controlled documents, and training courseware for cGMP & GDP Quality Assurance
  • Initiate QA deviations and CAPAs. Perform investigations and root cause analysis with oversight from QA Management

Education & Requirements:

  • BA/BS required with a preference in a scientific discipline
  • Minimum of 8 years' experience in pharmaceutical drug development, with the majority in the field of GMP quality assurance in the biopharmaceutical industry
  • Commercial product experience is a plus
  • Knowledge of global cGMP & GDP regulations and guidance's
  • Excellent verbal and written communication skills, with the ability to shape, frame, and present to diverse internal and external audiences
  • Ability to work with QA management team to meet timelines