Senior Manager, Quality Compliance

Company: bluebird bio
Location: Cambridge
Posted on: February 25, 2021

Job Description:

On January 11, 2021, we announced our intent to separate our severe genetic disease and oncology businesses into differentiated and independent publicly traded companies. We will retain focus on severe genetic disease (SGD) and will launch our oncology business ("Oncology Newco") as a new entity, with the completed transition expected by the end of 2021. ABOUT THE NEST At bluebird, only two things matter - patients and our people. When you join the nest, you're not just landing a new gig, you become a part of a flock that's soaring to new heights. We're 1100+ doers, thinkers and collaborators across the globe with a strong sense of our values and our purpose. Our innovation and sustainability are rooted in the diversity of our teams and results are achieved through cooperation and the incorporation of multiple points of view. This is personal and we approach every challenge with radical care. The time is now to rise up and recode the science, the systems, and the status quo. ABOUT THE FLOCK 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 the Quality team, the Senior Manager, Quality Compliance will support the integrated GMP audit and inspection management program. This position will support the internal and external audit program to meet all US and European requirements.
The Quality Compliance team supports Regulatory agency inspections and partner audits, drives responses to inspection findings, maintains the Approved Vendor List (AVL), leads inspection readiness efforts across 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, Supply Operations and Procurement to ensure supplier quality.
The Senior Manager, Quality Compliance must demonstrate strong auditing skills, attention to detail and will report to the Director, Quality Compliance.

HOW YOU'LL FLY

• Conduct, report, and oversee remediation of CMOs, CTO's and GMP vendor audits
• Schedule, execute, report and follow-up on internal and external GMP audits
• Review inspection audit reports to ensure accuracy and adherence to SOP requirements
• Ensure audit observations are communicated, tracked and remediated in compliance with internal policies as well as with all applicable regulatory requirements
• Assist with the development, maintenance and execution of the annual audit plan
• Compile program metrics as required
• Maintain the Approved Vendor List
• Collaborate and interact with various departments and levels of management to accomplish company objectives
• Support continuous improvement efforts through the monitoring of audit metrics
• Collaborate cross-functionally to develop and implement a robust audit program focused on overall performance
• Participate and support regulatory inspections
• Assist with inspection readiness efforts
• Monitor industry inspection trends, new/revised regulations and guidance for impact to operations
• Conduct GMP training when required
• Complete other tasks as required WHAT YOU'LL BRING You're the bird we're looking for if you:
  • Bachelor of Science degree in a scientific discipline is required
  • A minimum of 9 years industry experience within GMP Quality Assurance
  • Prior experience of hosting Regulatory and customer audits is required
  • Risk management experience is required
  • Highly motivated, flexible and have excellent organizational skills
  • Collaborative with partners and internal customers to advance the company's mission
  • Experienced working in Quality Assurance, Quality Systems and/or Quality Operations
  • Strong knowledge of global regulations (EU, US)
  • Understanding of GxPs with strong GMP experience
  • Excellent verbal and written communication skills
  • Ability to prioritize and balance work from multiple projects in parallel
  • Gene Therapy, PV, GCLP, and/or GLP experience is a plus
  • Ability to Travel 30%
  • Be ready to embrace the principles of the company's culture All our birds embrace the principles of the bluebird bio culture: b colorful, b cooperative, b yourself. bluebird bio is deeply committed to fostering an environment where diversity and inclusion are not only valued, but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities which strengthen our focus and fuel our growth. bluebird is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics. Will you now or in the future require bluebird bio to commence ("sponsor") an immigration case in order to employ you (for example, H-1B or other employment-based immigration case)? --*
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