Manager, Cmc Quality Assurance

Responsibilities:

• Reports directly to the Director of CMC QA, supporting CMC/GMP activities.
• Serve as QA primary point of contact for designated development programs attending routine update meetings and ensuring the actioning and completion of program-specific QA activities; provides QA review of project-specific planning documents, as needed.
• Support CMC QA document review (internal and external), as assigned:

• Prepares and agenda and minutes for Quality Assurance meetings as assigned.
• Prepares vendors for potential/impending audits and inspections
• Review and approve product stability protocol and reports
• Develop and deliver staff training on topics related to Quality, GxP Compliance, SOPs, and Risk Management as required
• Determine risk-based intervals for audits
• Manages internal GMP shipment procedures and approves shipments where required
• Review and approve master batch records, master labeling/packaging records, product specifications and other process related documents from contract sites.
• Write, revise, and periodically review SOPs to further develop the Quality System and demonstrate control over compliance and the quality of data, vendor services, and products
• Perform batch record and data review/approval. Prepares GMP batches for disposition and may perform batch disposition depending on experience.
• Conduct QA review of project-specific documents, as assigned
• Archives GMP Vendor Document as required according to internal practices.
• Review and approve manufacturing and analytical validation protocols and reports.
• Develop and obtain approval for Audit Schedules
• Review and/or approve deviations, OOSs, CAPAs, change control in an efficient manner for adequate and timely closeout of these events (internal and third-party as relevant).
• Develop eQMS workflows for quality procedures
• Conduct or assign an auditor to all scheduled GMP Vendor Audits
• Owner of vendor document management process
  • Archives GMP Vendor Document as required according to internal practices.
• Supports management and tracking of quality event records (including internal and external deviations, investigations, CAPAs, change controls, root cause analysis, risk assessments, complaints, etc.) including timely escalation of critical issues to department heads.
• Support Regulatory Compliance and Inspection Activities:
  • Prepares vendors for potential/impending audits and inspections
  • Conduct QA review of project-specific documents, as assigned
  • Supports the preparation, coordination, and management of regulatory agency inspections
• Supports the preparation, coordination, and management of regulatory agency inspections
• Utilize eQMS for quality workflows and for the effective tracking, trending, and reporting of quality data and information
  • Develop eQMS workflows for quality procedures
• Develops or performs initial review of draft quality agreements
• Clearly communicate quality, compliance, and audit issues to internal and external parties, professionally, and in a timely manner
• Perform other quality assurance duties as assigned by the Director of CMC QA
• Issues audit observations and develops and tracks response plans for GMP Vendor Audits
• Responsible for oversight of the GMP QA Vendor Qualification and Audit Program

Job characteristics:

• Working independently in a geographically distributed team
• Contributing to an overall culture of quality within the organization
• Leading cross-functional conversations and decision-making around complex quality, compliance, and risk situations
• Skilled in negotiation and communicating internally and externally with personnel of all levels of seniority

Requirements:

• Proficient written and verbal communication skills
• Drug Substance, manufacturing/manufacturing quality, experience working in a global environment a plus
• 5 or more years working in GMP Quality Assurance/Management with a BA in a scientific field
• Experience and expertise in conducting and reporting GXP vendor audits
• Experience working in clinical stage organization and applying phase appropriate quality principles
• Documented training on and knowledge of current FDA Regulations and GxPs