Please enable JS

Associate Director/Sr. Manager, Supplier Quality Management 

If interested and qualified, please include Requisition # 2018-315 in the subject line when emailing resume to:

For more information on CRISPR Therapeutics, please click here.

Position Summary

Reporting to the Director of GMP Quality, this position plays a lead role in the development, implementation and management of GMP Supplier Qualification & QA Monitoring in accordance with applicable global regulatory requirements and CRISPR Therapeutics business objectives. This position may require up to 30% travel. This is a high visibility position with great impact potential.


  • Lead all aspects of CRISPR Supplier Quality Management
  • Plan and conduct audits; write audit reports and observation letters; track open observations to closure
  • Provide quality oversight of third party CMO and Contract testing laboratories
  • Work collaboratively with internal and CMO technical and Quality staff in conducting Quality investigations to identify root cause and corrective / preventive actions
  • Collect and analyze Quality Metrics and provide risk based updates to CRISPR Sr. Management
  • Work with Technical Operations and Manufacturing on qualification of new suppliers, including identification of supplier risks and mitigation strategies
  • Manage supplier change notifications and work with stakeholders to determine impact to product quality
  • Maintain current knowledge of Regulatory and Industry trends as it relates to cGMP vendor oversight

Minimum Qualifications

  • BS in Biological Sciences, Engineering, or related fields; advanced degree preferred
  • Minimum 7-10 years of relevant industry experience including at least 5 years in QA GMP Supplier Qualification and CMO Quality oversight
  • Significant experience in biologics drug substance & drug product manufacturing; knowledge of gene based drug development preferred
  • Experience on use of quality investigative tools including FMEA's, DMAIC, and Process Mapping
  • Extensive knowledge of Quality Systems and FDA/International agencies cGMP regulations
  • Strong analytical, problem solving, and critical thinking skills; Self-starter and action-oriented
  • Excellent time management skills; able to handle multiple projects with high attention to detail
  • Excellent oral and written communication skills with internal and external organizations
  • Ability to travel up to 30% of the time
  • Ability to influence others and work independently and in a team matrix
  • Experience in authoring and negotiating Quality Agreements
  • Working knowledge of QMS electronic platforms e.g. Veeva, Pilgrim, TrackWise, etc.,


  • Adaptability/Flexibility The ability to adapt to working effectively within a variety of situations; adapts enthusiastically to organizational change and to changes in job demands.
  • Communication and Teamwork – The ability to effectively express ideas in written and oral context. The ability to work co-operatively with others; genuine desire to be part of a team and contribute to team goals.
  • Effective Planning - Embedding discipline and thoroughness in our approaches.
  • Perseverance – Pursues tasks with energy, drive and initiative, even in the face of adversity.
  • Problem Solving – Able to understand a situation, task or problem by breaking it down into smaller pieces using a systematic approach to identify patterns between situations that are not obviously related.
  • Relationship Building – Builds productive working relationships across a diverse spectrum of people.

If interested and qualified, please include Requisition # 2018-315 in the subject line when emailing resume to:

For more information on CRISPR Therapeutics, please click here.