Manager, Quality Management Systems
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Summary & Scope of Position:
The Manager, Quality Management Systems (QMS), will be responsible for the improvement, design, development, implementation and maintenance of the GxP QMS processes at Aduro Biotech. This includes, but is not limited to, Change Control, Deviation and other Non-conformances, CAPA, Equipment/Instrument associated systems, Supplier Management, and Risk Management. The role is focused on improving and maintaining the business processes and will include being the Quality Lead on the implementation of IT solutions/systems. The Manager will address gaps associated with the current processes as part of preparing for current and future clinical operations of Aduro s products.
Lead the development, continuous improvement and implementation of Quality Systems
Improve Change Control, Supplier Management and CAPA processes
Improve and establish standard operating procedures for efficient and compliant management of GxP QMS processes
Establish and track quality metrics for QMS processes and present improvement opportunities at Management Review meetings
Implement risk management based approaches
Conduct domestic and international Quality System audits (e.g., CMO Qualification, Assessement, For Cause, and/or Periodic audits) to ensure that the sites operate in compliance with EU/FDA/ICH and other regulatory bodies as may be required and remain GMP inspection ready at all times.
Interface with FDA / EU and other regulatory agencies, customers and consultants
Represent QA on cross-functional teams to complete projects, address quality issues and implement quality system improvements
Identify compliance gaps and leading focused teams to resolve compliance issues. Provide written compliance assessments to management on request, and interpreting global regulations and applying them to a multi-product, multi-modality environment.
Develop, or review, Operating Procedures (SOPs) required for supporting system change/enhancement to ensure compliance with Good Manufacturing Practices (GMPs) requirements
Establish and maintain policies and procedures to ensure compliance with local, state and federal environmental regulations and standards including compliance with all Food & Drug Administration (FDA) and all other applicable global regulatory requirements
Establish and oversee internal quality systems and policies throughout the company.
Responsible for the co-ordination and preparation of activities related to regulatory agency inspections at company facilities, CMO s, vendors and investigator study sites.
Prepare GXP quality metrics; analyze data relating to process validations, process controls, and continuous process improvement efforts; coordinate the necessary quality adjustments.
Provides QA support to IT projects as needed.