Manager, Internal Quality Operations

Company: 2seventy Bio
Location: Cambridge
Posted on: May 25, 2023

Job Description:

How you'll make an impact:
We are looking to add to our team of innovators, disruptors, and caregivers. This role will play a pivotal part in how we deliver more than just treatment to our patients; it will enable us to deliver hope.
About the team:
The internal QA Operations Team supports and oversees resolution of quality issues encountered with cGMP drug product manufacturing, lot release testing, and raw material management at our Cambridge site. Operational support is also given to teams with responsible for facility management, equipment validation and sample management. There will be external vendor relationships and communications needed to support efficient and compliant processes and program management. Also provide Quality Assurance support for additional Quality teams responsible for the resolution of quality issues encountered with lot release and testing of early phase programs.
How you'll spend your time:

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• Provide oversight and leadership for the Internal Operations QA team focused on manufacturing activities.
  
• On-the-floor support of Manufacturing activities during times of production.
  
• Management of data review, analysis, identification of trends, and complex problem solving.
  
• Review and approve documents including master batch records, qualification protocols and reports, lab investigations, retest plans, deviations, expiration extensions and supporting trend analyses, and change controls.
  
• May be called on to assist in manufacturing batch record review and review of internal documentation and forms in support of product lot release.
  
• Prepare and review documentation associated with deviations, investigations, OOS results, and CAPA action plans.
  
• Ensure all documentation complies with cGMP regulations and industry guidelines. Identify quality issues and effectively and proactively resolve them in a diplomatic, flexible, and constructive manner.
  
• Engage in activities to continuously assess and improve Quality processes. Support the development, implementation, and revision of corporate quality systems.
  
  Who you are and what you've accomplished:
  
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  • This role is at the Manager level but for the right candidate, we would hire at the Senior Manager level (commensurate with experience)
    
  • BA/BS and a minimum of 6 years in Quality Assurance, Manufacturing and/or Science and Technology. Experience supporting internal or external manufacturing highly desired.
    
  • Experience with facility start up, commissioning and qualification of equipment, instruments and utilities, Phase 1 clinical drug product manufacturing, validation principles and material management are all pluses.
    
  • Experience and/or knowledge of cellular therapy collection, processing, and upstream manufacturing beneficial, but not required.
    
  • Experience with deviation investigations, OOS lab investigations, change control, CAPA development and process improvements.
    
  • Demonstrated knowledge of GxP regulations, quality systems, and phase appropriate cGMP.
    
  • Proven leadership ability with experience managing through change and ambiguity.
    
  • Excellent organizational and project management skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities and multiple stakeholders
    
  • Experience interacting with external vendors, contract testing organizations, including identifying, communicating, and resolving complex issues
    
  • Experience with impact and risk assessment tools, process mapping and process improvement tools
    
  • You should enjoy pushing limits, creating solutions, and working within a highly motivated culture where our mission - to offer patients and their families more time - is at the heart of all we do.
    
  • Looking to solve difficult, messy problems like developing cell therapies for cancer-it's hard!
    
  • Ability to communicate above and below level in a way that fosters relationship building, including cross-functional teams, and external relationships with vendors
    
  • Successfully worked in a collaborative team environment where results are achieved through influence and incorporating multiple points of view
    
  • Must have excellent attention to detail, project and time management skills, and the ability to manage multiple priorities
    
  • Embraces and models our core values-re:think, have:heart, better:2gether, time:is now
    
    

Keywords: 2seventy Bio, Cambridge , Manager, Internal Quality Operations, Executive , Cambridge, Massachusetts