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Associate Director, Quality Compliance

Bluebird Bio, Cambridge, Massachusetts, United States

integrated product platforms with broad therapeutic potential


Join bluebird bio’s enthusiastic and collaborative Quality Compliance team to contribute to the overall success of our novel gene therapy.  As a key member of bluebird bio’s Quality team, the Associate Director, Quality Compliance will be responsible for developing, implementing and leading compliance strategies in alignment with global regulations.  This position will have oversight of the Apheresis and Treatment Center Audit Program to meet all US, European and global Good Manufacturing Practice (GMP) and Good Tissue Practice (GTP) requirements.  

bluebird bio’s Quality Compliance team supports regulatory agency inspections and partner audits, assists with responses to inspection findings, maintains the Approved Vendor List (AVL), supports inspection readiness efforts across bluebird bio operations, manages the Auditor Qualification Program and is responsible for the GxP Audit Program.  Additionally, Quality Compliance works closely with Vendor Management, Clinical Development Operations, Apheresis Operations, Commercial Operations and Supply Operations to ensure vendor quality.

The Associate Director, Quality Compliance must demonstrate strong managerial skills, mentor junior members in the group and will report to the Director, Quality Compliance.

About the role:

  • A managerial role expected to embrace bluebird bio’s Core Values; b colorful, b cooperative, and b yourself
  • Manage compliance and monitoring systems for Apheresis and Treatment Centers and associated services
  • Schedule, execute and follow-up on Apheresis and Treatment Center audits
  • Ensure audit observations are communicated, tracked and remediated in compliance with internal policies as well as with all applicable regulatory requirements
  • Maintain the Approved Vendor List
  • Assist with inspection readiness efforts
  • Collaborate with internal stakeholders (Apheresis Operations, Commercial and Clinical Development) to coordinate and prioritize Treatment Center audits
  • Support continuous improvement efforts through the monitoring of audit metrics
  • Manage an efficient and effective risk-based audit program, escalating issues as needed
  • Support GxP regulatory inspections as required
  • Assist with the development, maintenance and execution of the annual audit plan
  • Provide performance reviews, development plans and set goals for department staff in alignment with company goals
  • Monitor industry inspection trends, new/revised regulations and guidance for impact to bluebird bio operations

 

About You:

  • Ability to build relationships and influence across disciplines and all levels
  • Desire to share expertise and mentor junior members of the team
  • Strong written and verbal communication skills
  • Highly motivated, flexible and organized
  • Collaborative with partners to advance the bluebird bio mission
  • Experienced manager in Quality Assurance, Quality Systems and/or Quality Operations
  • Knowledge and application of GTP and GMP regulations (US & EU) and FACT/JACIE requirements
  • Ability to prioritize and balance work from multiple projects in parallel
  • Bachelor of Science degree in a scientific discipline is required
  • A minimum of 12 years of experience in the industry
  • Gene therapy, cellular therapy, GVP or GCP experience a plus
  • Ability to Travel (30%)
  • Be ready to embrace the principles of the bluebird bio culture:  b colorful, b cooperative, and b yourself 

About Bluebird Bio

About us We are leading the gene therapy revolution. Our integrated product platforms encompass gene therapy, cancer immunotherapy and gene editing – providing us with the potential to treat, and hopefully cure, a broad range of serious diseases. We have a lot of energy, and it’s not just the abundance of coffee that keeps us going. Find out what sparks our excitement and inspires us every day.

Want to learn more about Bluebird Bio? Visit Bluebird Bio's website.